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National Clinical Guideline Centre (UK). The Prevention and Management of Pressure Ulcers in Primary and Secondary Care. London: National Institute for Health and Care Excellence (NICE); 2014 Apr. (NICE Clinical Guidelines, No. 179.)
Debridement is the removal of necrotic tissue from a wound. Generally, the presence of necrotic or dead tissue is seen as a delaying factor in pressure ulcer healing, preventing the formation of healthy granulation tissue and a good environment to harbour more bacteria, thereby increasing the risk of further sepsis.
Necrotic tissue is removed during natural wound healing due to autolytic debridement and this process may be helped by the application of a moist wound dressing. Other forms of debridement include enzymatic (via an agent impregnated in a dressing or applied directly to the pressure ulcer), mechanical (via the physical removal of dead tissue by water either under low or high pressure or by allowing a dressing to stick to the pressure ulcer before removal (wet to dry dressing)) and sharp debridement. Sharp debridement includes debridement of totally dead or necrotic tissue using a scalpel or scissors and the more extensive removal of tissue under anaesthesia (when a surgeon removes enough tissue until tissue with a good bleeding capillary base is found.
The choice of debridement method depends upon the nature of the wound, the skill set of the practitioner, access to equipment and dressings, and the condition of the individual. Given the range of debridement options available, the GDG was interested in identifying the most effective method of debridement of non-viable tissue to treat pressure ulcers.
8.1. Review question: What are the most clinically and cost effective methods of debridement of non-viable tissue for the treatment of pressure ulcers?
For full details see review protocol in Appendix D.
8.1.1. Clinical evidence (adults)
Nine randomised trials were identified as meeting the inclusion criteria and were included in this review. All study evidence tables and forest plots are presented in Appendix G and I.
Summry of included studies
| Study | Intervention/comparator | Population | Outcome | Length of study |
|---|---|---|---|---|
| Agren,19854 | Zinc oxide Streptokinase-streptodornase ointment. | Geriatric adults with necrotic pressure ulcer. |
| 8 weeks of treatment |
| Alvarez, 20008 | Collagenase ointment (Santyl) versus papain/urea ointment (Accuzyme). | People with pressure ulcers requiring debridement, who were stable or improving after a 2 week screening period. |
| 2 weeks screening and 4 weeks period of the study |
| Burgos, 2000 (a)36 | Collagenase ointment (Iruxol) versus hydrocolloid dressing (Varihesive). | People of at least 55 years presenting with grade 3 pressure ulcers (skin disruption, tissue damage and exudate and subcutaneous tissue involvement). |
| 12 weeks of treatment or until healing of the pressure ulcer, whichever occurred first. |
| Burgos, 2000 (b)35 | Collagenase ointment application every 24 hours versus collagenase ointment application every 48 hours. | Hospitalised or institutionalised people aged 55 years or older presenting with grade 3 pressure ulcer for less than 1 year. |
| Treatment during maximum 8 weeks or until complete healing of the pressure ulcer whatever occurred first. |
| Lee, 1975103 | Collagenase ointment (Santyl) versus preparation of inactivated collagenase. | 11 adults with chronic diseases. Four had neoplastic disease; 4 atherosclerotic heart diseases or cerebrovascular accident or both; 2 had Parkinson's disease and 1 had a femoral neck fracture. |
| 4 weeks of treatment and follow-up unless complications developed or participant died. |
| Milne, 2012, 2010117 | Colleganase ointment (Santyl) versus hydrogel dressing (SoloSite Gel). | People in a long-term care facility. |
| 84 days |
| Müller 2001125 | Hydrocolloid dressing (Duoderm) versus collagenase dressing (Novuxol). | Females with a grade 4 heel pressure ulcers |
| Maximum 16 weeks |
| Parish, 1979146 | Dextranomer powder (Debrisan) versus collagenase ointment (Santyl) versus sugar and egg white. | People with pressure ulcers in a long-term care institution for the chronically ill and physically disabled. |
| The initial study was to have lasted 4 weeks, but many subjects were treated and observed for up to 4 months or longer. |
| Püllen, 2002152 | Twice-daily treatment with collagenase ointment (1.2 U/g) (Novuxal) versus twice-daily treatment fibrinolysin/DNAse ointment (1 U Loomis and 666 Christensen/g) (Fibrolan) | Adults with pressure ulcers, Seiler grade 2,3 or 4, in the pelvic region with fibrinous or necrotic slough from 17 hospitals. |
| Four weeks of treatment or until complete wound debridement whichever occurred first. |
Table 74
Clinical evidence profile: collagenase ointment versus preparation of inactivated collagenase.
Table 75
Clinical evidence profile: collagenase ointment versus dextranomer.
Table 76
Clinical evidence profile: collagenase ointment versus sugar and egg white.
Table 77
Clinical evidence profile: collagenase ointment versus papainm and urea ointment.
Table 78
Clinical evidence profile: collagenase ointment versus fibrinolysis/DNAse ointment.
Table 79
Clinical evidence profile: collagenase ointment versus hydrocolloid dressing.
Table 80
Clinical evidence profile: collagenase ointment application every 24 hours versus every 48 hours.
Table 81
Clinical evidence profile: collagenase ointment versus hydrogel dressing.
Table 82
Clinical evidence profile: zinc oxide versus streptokinase-streptodornase ointment.
8.1.1. Economic evidence (adults)
Five studies were included with relevant comparisons.27,36,121,125 These are summarised in the economic evidence profiles below (Table 83- Table 87). See also the study selection flow chart in Appendix C and study evidence tables in Appendix F.
Table 83
Economic evidence profile: hydrocolloid dressing versus collagenase dressing.
Table 84
Economic evidence profile: hydrogel dressing versus collagenase dressing.
Table 85
Economic evidence profile: gauze versus impregnated gauze versus calcium alginate versus hydroactive wound dressing (with collagenase).
Table 86
Economic evidence profile: autolysis versus wet-to-dry dressings versus collagenase versus fibrinolysin.
Two of the included studies36,125 compare collagenase ointment to a hydrocolloid dressing (Table 190). However, the conclusions of these 2 studies differ; Burgos and colleagues (2000) found collagenase ointment to be more effective and more costly than hydrocolloid dressing, whereas Müller and colleagues (2001) found collagenase to be more effective and less costly than hydrocolloid. This is because a higher proportion of people were heeled in the Müller study compared to the Burgos study (Appendix H), and a greater incremental difference in people healed between the trail arms can be seen. This could be partly due to the differences in the populations studied in the trials. The Burgos study was based in Spain (costs are calculated in Spanish pesetas) amongst a group which was 46% male and all of whom had stage 3 pressure ulcers. The Müller study, on the other hand, was conducted in Holland (costs are calculated in Dutch guilders), amongst a population who were all female, and all had stage 4 heel pressure ulcers. Note also that the time horizon of the Müller study was 16 weeks, compared to 12 weeks in the Burgos study.
Both studies report that collagenase was applied once daily and hydrocolloid every 3 days (or twice a week). Consequently, Burgos and colleagues report higher staff and auxiliary supply costs (per patient) in the collagenase group than in the hydrocolloid group. The higher staff cost and ancillary supplies required for the more frequent dressing changes in the collagenase arm result in this arm being more costly per person than the hydrocolloid arm, despite a lower pharmaceutical cost of collagenase. However, Müller and colleagues report lower personnel costs for collagenase than for hydrocolloid. They attribute this to fewer doctors' appointments required in the collagenase group due to a shorter healing time. Müller and colleagues find personnel costs and material costs to be lower in the collagenase arm, and thus conclude collagenase is cheaper than hydrocolloid.
One study that met the inclusion criteria was selectively excluded191 – this is summarised in Appendix K, with reasons for exclusion given.
8.1.2. Clinical evidence (neonates, infants, children and young people)
No RCTs or cohort studies were identified. Recommendations were developed using a modified Delphi consensus technique. Further details can be found in Appendix N.
8.1.3. Economic (neonates, infants, children and young people)
No economic evidence was identified.
8.1.4. Evidence statements
8.1.4.1. Clinical (adults)
8.1.4.1.1. Collagenase ointment versus preparation of inactivated collagenase
- One study (n=28) showed collagenase ointment is potentially more clinically effective for decreasing volume of pressure ulcers compared to a preparation of inactivated collagenase (very low quality).
- One study (n=28) showed inactivated collagenase is potentially more clinically harmful for increasing the size of volume of pressure ulcers compared to collagenase ointment (very low quality).
- One study (n=28) showed there may be no clinical difference between collagenase ointment and a preparation of inactivated collagenase for proportion of pressure ulcers with odour at the end of treatment, the direction of the estimate of effect favoured collagenase (very low quality).
- One study (n=28) showed there may be no clinical difference between collagenase ointment and a preparation of inactivated collagenase for side effects, the direction of the estimate of effect favoured the preparation of inactivated collagenase (very low quality).
- One study (n=28) showed there is no clinical difference between collagenase ointment and a preparation of inactivated collagenase for mortality (all-cause) (low quality).
- No evidence was found for the following outcomes:
- Proportion of people with pressure ulcers completely healed
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Health-related quality of life
8.1.4.1.2. Collagenase ointment versus dextranomer powder
- One study (n=28) showed dextranomer may be more clinically effective for complete healing of pressure ulcers when compared to collagenase ointment (very low quality).
- One study (n=25) (chronically ill and disabled people) showed dextranomer may be more clinically effective for proportion of people with complete healing of pressure ulcers when compared to collagenase ointment (very low quality).
- One study (n=25) showed dextranomer is potentially more clinically effective for proportion of pressure ulcers improved when compared to collagenase ointment (very low quality).
- One study (n=28) showed dextranomer is potentially more clinically effective for proportion of people with pressure ulcers improved when compared to collagenase ointment (very low quality).
- One study (n=28) showed dextranomer is potentially more clinically effective for proportion of people with pressure ulcers improved after 1 week when compared to collagenase ointment (very low quality).
- One study (n=28) showed dextranomer is potentially more clinically effective for proportion of people with pressure ulcers improved after 1 month when compared to collagenase ointment (very low quality).
- One study (n=28) showed dextranomer may be more clinically effective for proportion of people with pressure ulcers improved after 2 months when compared to collagenase ointment (very low quality).
- One study (n=28) showed dextranomer is potentially more clinically effective for proportion of people with pressure ulcers improved after over 2 months when compared to collagenase ointment (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all-cause)
- Health-related quality of life
8.1.4.1.3. Collagenase ointment versus sugar and egg white
- One study (n=20) showed collagenase ointment may be more clinically effective for proportion of people with pressure ulcers completely healed when compared to sugar and egg white (very low quality).
- One study (n=20) showed collagenase ointment may be more clinically effective for complete healing of pressure ulcers when compared to sugar and egg white (very low quality).
- One study (n=20) showed collagenase ointment may be more clinically effective for improving pressure ulcers when compared to sugar and egg white (very low quality).
- One study (n=20) showed collagenase ointment no clinical difference between sugar and egg white for improving pressure ulcers at 1 week, the direction of estimate of effect could favour either intervention (low quality).
- One study (n=20) showed collagenase ointment may be more clinically effective for improving pressure ulcers when compared to sugar and egg white at 1 month (very low quality).
- One study (n=20) showed collagenase ointment is more clinically effective for improving pressure ulcers when compared to sugar and egg white at 2 months (low quality).
- One study (n=20) showed collagenase ointment is more clinically effective for reducing proportion of people with pressure ulcers when compared to sugar and egg white (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all-cause)
- Health-related quality of life
8.1.4.1.4. Collagenase ointment versus papain/urea ointment
- One study (n=21) showed there may be no clinical difference between collagenase ointment and papain/urea for reducing pressure ulcers size (%) at 1 week, the direction of estimate of effect favoured papain/urea (very low quality).
- One study (n=21) showed there may be no clinical difference between collagenase ointment and papain/urea for reducing pressure ulcers size (%) at 2 week2, the direction of estimate of effect favoured papain/urea (very low quality).
- One study (n=21) showed there may be no clinical difference between collagenase ointment and papain/urea for reducing pressure ulcers size (%) at 3 week2, the direction of estimate of effect favoured papain/urea (very low quality).
- One study (n=21) showed there may be no clinical difference between collagenase ointment and papain/urea for reducing pressure ulcers size (%) at 4 weeks, the direction of estimate of effect favoured papain/urea (very low quality).
- One study (n=21) showed collagenase ointment may be more clinically harmful than papain/urea for adverse events observed (very low quality).
- No evidence was found for the following outcomes:
- Proportion of people with pressure ulcers completely healed
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Mortality (all-cause)
- Health-related quality of life
8.1.4.1.5. Collagenase ointment versus fibrinolysis/DNAse ointment
- One study (n=135) showed collagenase ointment is potentially more clinically harmful than fibrinolysis/DNAse for adverse events observed (very low quality).
- One study (n=135) showed collagenase ointment is more clinically harmful than fibrinolysis/DNAse for serious adverse events observed (low quality).
- No evidence was found for the following outcomes:
- Proportion of people with pressure ulcers completely healed
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Reduction in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Mortality (all-cause)
- Health-related quality of life
8.1.4.1.6. Collagenase dressing versus hydrocolloid dressing
- One study (n=37) showed no clinical difference between collagenase dressing and hydrocolloid dressing for reducing pressure ulcer area (very low quality).
- One study (n=37) showed collagenase dressing may be more clinically effective than hydrocolloid dressing for complete healing of pressure ulcers (very low quality).
- One study (n=37) showed there may be no clinical difference between collagenase dressing and hydrocolloid dressing for mean reduction in pressure ulcer area, the direction of the estimate of effect favoured the collagenase dressing (very low quality).
- One study (n=37) showed there may be no clinical difference between hydrocolloid dressing and collagenase dressing for adverse events observed, the direction of estimate of effect favoured collagenase (very low quality).
- One study (n=22) showed collagenase dressing may be more clinically effective than hydrocolloid dressing for delaying time to complete healing of pressure ulcers (very low quality).
- Two studies (n=61) showed there may be no clinical difference between collagenase dressing and hydrocolloid dressing for mortality, the direction of effect favours the hydrocolloid dressing (very low quality).
- No evidence was found for the following outcomes:
- Rate of change in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Health-related quality of life
8.1.4.1.7. Collagenase ointment 24 hours versus 48 hour application
- One study (n=86) showed there may be no clinical difference between collagenase ointment applied 24 hours compared to 48 hours for the proportion of pressure ulcers completely healed, the direction of effect favours 24 hours (very low quality).
- One study (n=92) showed there may be no clinical difference between collagenase ointment applied 24 hours compared to 48 hours for adverse events observed, the direction of effect could favour either application (very low quality).
- One study (n=86) showed there may be no clinical difference between collagenase ointment applied 24 hours compared to 48 hours for mortality, the direction of effect favours 24 hours (very low quality).
- No evidence was found for the following outcomes:
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Reduction in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Health-related quality of life
8.1.4.1.8. Collagenase ointment versus hydrogel dressing
- One study (n=27) showed collagenase ointment is potentially more clinically effective than hydrogel for proportion of people with pressure ulcers completely healed (very low quality).
- One study (n=27) showed there may be no clinical difference between collagenase ointment and hydrogel for reducing mean PUSH tool score, direction of estimate of effect favours collagenase (very low quality).
- One study (n=27) showed no clinical difference between collagenase ointment and hydrogel for mortality (low quality).
- No evidence was found for the following outcomes:
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Reduction in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all-cause)
- Health-related quality of life
8.1.4.1.9. Zinc oxide versus streptokinase-streptodornase ointment
- One study (n=28) reported zinc oxide ointment may be more effective at reducing percentage of ulcer area compared to streptokinase-streptodornase. The clinical importance is unknown (very low quality).
- One study (n=28) showed that there may be no clinical difference between zinc oxide and streptokinase-streptodornase ointment for proportion of people with an infection, the direction of the estimate of effect favours zinc oxide (very low quality).
- One study (n=28) showed that there may be no clinical difference between zinc oxide and streptokinase-streptodornase ointment for proportion of people with a skin reaction, the direction of the estimate of effect favours zinc oxide (very low quality).
- One study (n=28) showed there is no clinical difference between zinc oxide and streptokinase-streptodornase ointment for mortality (all-cause), the direction of the estimate of effect could favour either intervention (low quality).
- No evidence was found for the following outcomes:
- Proportion of people with pressure ulcers completely healed
- Time to complete healing of pressure ulcers
- Rate of change in size or volume of pressure ulcers
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all-cause)
- Health-related quality of life
8.1.4.2. Economic (adults)
- One cost-effectiveness analyses found collagenase is likely to be more expensive and more effective than hydrocolloid for healing people with pressure ulcers; 1 additional cost-effectiveness analysis found that collagen is likely to dominate hydrocolloid (collagen is less costly and more effective) in the treatment of heel pressure ulcers. Both studies were partially applicable with potentially serious limitations.
- One cost-consequence analysis found collagenase dressings dominate hydrogel dressings, with lower costs and fewer days spent with a pressure ulcer. This study was assessed to be partially applicable with potentially serious limitations.
- One cost comparison found the combination of a hydroactive wound dressing and collagenase to be less costly than gauze, impregnated gauze and calcium alginate. This study was partially applicable with potentially serious limitations.
- One cost comparison found collagenase to be less costly than autolysis, wet-to-dry saline dressings and fibrinolysin and desoxyribonuclease combined. This study was partially applicable with potentially serious limitations.
8.1.4.3. Clinical (neonates, infants, children and young people)
No evidence was identified.
8.1.4.4. Economic (neonates, infants, children and young people)
No relevant economic evaluations were identified.
8.2. Maggot (larval) therapy
Maggot therapy, also known as larval therapy, is an alternative method of debridement. The maggots used for debridement are from sterile fly larvae of the sheep blowfly Luciliasericata (Diptera: Calliphoridae). These maggots are ideal for debridement because the enzymes produced by this species dissolve only dead tissue in human wounds, thus the maggots are unable to damage healthy tissue. Maggot secretions also contain chemicals with inherent antimicrobial properties, which may help to combat infection by having an inhibitory effect on the growth of bacteria. In addition it has been postulated that maggot therapy may result in more rapid debridement and less pain than some other therapies.
The GDG was interested in identifying the the most clinical and cost effective method of maggot debridement.
8.3. Review question: What are the most clinically and cost effective methods of maggot debridement of non-viable tissue for treatment of pressure ulcers?
For full details see review protocol in Appendix D.
8.3.1. Clinical evidence (adults)
No randomised trials were identified for inclusion of the review, therefore a search for cohort studies was conducted (as per the protocol in Appendix C). Three records were subsequently included in this review. Evidence from these studies is summarised below and the clinical GRADE evidence profiles in Table 74 onwards. All study evidence tables and forest plots are presented in respectively Appendix G and Appendix I.
Summary of studies included in the review
| Study | Intervention/comparator | Population | Outcome | Length of study |
|---|---|---|---|---|
| Sherman, 1995175 | Maggot therapy administered by disinfected fly larvae of the species Phaeniciasericata versus conventional treatment. | Participants with pressure ulcers stage 3 or 4 for at least 1 month. |
| Participantswere followed up for 3 to 4 weeks prior to maggot therapy |
| Sherman, 2002174 | Maggot therapy administered by applying disinfectedfly larvae (Phaeniciasericata) to the wound at a density offive to eight per cm2 versus conventional treatment prescribed by their primary care provider or the hospital's wound care team. | People with pressure ulcers. |
| Wounds were first followed for 2 to 8 weeks (average 4.8 weeks) while still receiving conventional therapy. Then the wounds were treated for 2 weeks or more (average 5.2 weeks) with maggot therapy. |
| Wang, 2010204 | Maggot therapy administered by applying disinfected larvae of Luciliasericata to the wound at a density of 5 to 10 per cm2 versus a dressing applied daily with normal saline only and if necessary surgical debridement. | People with pressure ulcers after spinal cord injury treated in the hospital. |
| All participants were followed up for 2 to 6 months (mean 3.5 months). |
Table 87
Clinical evidence profile: maggot therapy versus conservative treatment.
8.3.2. Economic evidence (adults)
Published literature
No relevant economic evaluations were identified. One study that met the inclusion criteria was selectively excluded191 - reasons for exclusion are given in Appendix K.
Unit costs
To aid consideration of cost effectiveness, relevant unit costs were obtained from the UK supplier of maggots (BioMond UK). List prices indicate that a 5×6cm BioBag (without sudocrem) costs £245. Assuming (based on GDG estimate) that each patient has a maximum of 3-4 applications, the cost of debridement with maggots could cost up to £980.
8.3.3. Clinical evidence (neonates, infants, children and young people)
No RCTs or cohort studies were identified. Recommendations were developed using a modified Delphi consensus technique. Further details can be found in Appendix N.
8.3.4. Economic evidence (neonates, infants, children and young people)
No relevant economic evaluations were identified.
8.3.5. Evidence statements
8.3.5.1. Clinical (adults)
- One study (n=92) reported maggot therapy was more clinically effective than conservative treatment for reducing the surface area of pressure ulcers during treatment (very low quality).
- One study (n=92) showed that there may be no clinical difference between maggot therapy and conservative treatment for the change in surface area per week. The direction of the effect favoured maggot therapy (very low quality).
- One study (n=92) showed that maggot therapy was more clinically effective than conservative treatment for decreasing the surface area of pressure ulcers within 4 weeks (very low quality).
- One study (n=92) showed that there is no clinical difference between maggot therapy and conservative treatment for healing rate at 8 weeks. The direction of the effect favoured maggot therapy (very low quality).
- One study (n=92) showed that there is potentially no clinical difference between maggot therapy and conservative treatment for the proportion of wounds completely healed. The direction of the effect favoured the maggot therapy (very low quality).
- Two studies (n=110) showed that maggot therapy is potentially more clinically effective than conservative treatment for time to wound healing (very low quality).
- No evidence was found for the following outcomes:
- Pain (wound-related)
- Time in hospital or NHS care
- Patient acceptability
- Side effects
- Mortality (all-cause)
- Health-related quality of life
8.3.5.2. Economic (adults)
No economic evidence was identified.
8.3.5.3. Clinical (neonates, infants, children and young people)
No evidence was identified.
8.3.5.4. Economic (neonates, infants, children and young people)
No economic evidence was identified.
8.4. Recommendations and link to evidence
8.4.1. Adults
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. This recommendation was developed from GDG consensus after reviewing the evidence for debridement, to establish whether debridement is required and what type of debridement would be preferable. |
| Trade-off between clinical benefits and harms | In order to determine whether debridement should be carried out for the treatment of pressure ulcers, the GDG considered evidence looking at different debridement techniques. There was no evidence comparing different techniques of debridement except for the comparison of enzymatic debridement to autolytic debridement (with the use of hydrogel or hydrocolloid dressings). Enzymatic debridement (collagenase) showed some benefit over autolytic debridement (hydrogel dressing). However the GDG noted that there were certain benefits in allowing debridement to occur naturally, as enzymatic debridement can result in the removal of tissue which might otherwise survive. The GDG felt that the use of collagenase was slower than the use of surgical debridement, and therefore surgical debridement would be preferential over enzymatic debridement. Despite the lack of evidence, the GDG considered that debridement is required physiologically for the healing process in some pressure ulcers. Therefore, in order to identify where this would be required, the GDG felt that it was necessary to assess the pressure ulcer. The group therefore used informal consensus to develop a list of considerations to aid an assessment of need for and technique of debridement. The GDG felt that an experienced individual should carry out the debridement. Careful consideration would be needed as to who this should be and in what environment this should be done. The GDG noted that debridement can also be carried out in the community. There is also a need to consider if specialist referral is appropriate. Debridement should be prompt and timely to ensure that there is no delay in initiating treatment. The timing of debridement methods should be dependent upon the individuals clinical need. |
| Economic considerations | The GDG considered the economic implications of debridement. It was agreed that debridement was necessary to promote healing in some cases, and has long term benefits in the form of improved quality of life and reduced treatment costs. The GDG considered 5 economic evaluations which assessed different methods of debridement, all of which were only partially applicable, and had potentially serious limitations. All 5 analyses indicated that collagenase (enzymatic debridement) is cost-effective (compared to hydrocolloid dressings, hydrogel dressings, gauze, calcium alginate, autolysis, wet-to-dry dressings and fibrinolysin). However, none of these studies were from the UK, and pressure ulcers are not a licensed indication for the use of collagenase in the UK. Due to the limitations of these studies and the limited applicability in a UK NHS setting, the GDG felt that these studies were of little benefit in determining cost-effectiveness, and noted that a more relevant comparison would be sharp debridement compared to enzymatic debridement. The GDG agreed that where debridement was required, it is likely that sharp debridement would be cost effective compared to other methods, as it is a quicker process, thus healing can begin sooner and quality of life improvements realised from an earlier stage. In most cases, sharp debridement does not require anaesthetic as only dead tissue is removed, and can be done at the bedside, meaning it can be achieved quickly and efficiently. The GDG did note however, that in a small number of cases sharp debridement would need to be conducted in an operating theatre which would increase the cost on these occasions. The GDG agreed that the upfront cost of sharp debridement would be offset by future savings from a reduced time to healing and improvements in quality of life. The GDG noted that where autolytic debridement was likely to be sufficient, this method of debridement would be likely to offer a cost-effective solution, as it requires no additional resources over the use of an appropriate dressing (as recommended in Chapter 10. The GDG therefore agreed that where active steps for debridement are required sharp debridement is likely to be the cost-effective strategy, and where autolytic debridement is likely to be sufficient, autolytic debridement is likely to be the cost-effective option. No economic evaluations were included which assessed the cost-effectiveness of larval therapy for debridement; therefore the GDG considered relevant unit costs. The GDG noted that debridement with maggots is substantially more expensive than debridement by other means. As there was limited clinical evidence to suggest a benefit of using larval therapy, the GDG did not think that the additional cost was justified. Larval therapy is not considered to be cost-effective compared to other methods of debridement. |
| Quality of evidence | This recommendation was based on the GDG's experience and was developed after reviewing the limited evidence for debridement. Maggot therapy No randomised trials were found, therefore cohort studies were included in the review. The majority of outcomes came from 1 cohort study. The evidence was limited to 3 cohort studies which had very serious limitations and small sample sizes. There was no serious imprecision for the proportion of pressure ulcers decreased in surface area and healing rate. There was serious imprecision for the proportion of pressure ulcers completely healed and time to healing. The conventional treatment involved a variety of treatments including dressings, surgical and enzymatic debridement. Enzymatic debridement The evidence was weak as the studies had small sample sizes and the evidence was downgraded for serious and very serious imprecision for almost all outcomes. All the studies had very serious risk of bias. Therefore there is a lot of uncertainty in the results. The GDG noted that outcomes such as reduction in the area of pressure ulcer were sometimes difficult to interpret as debridement may increase the size of the wound whilst being beneficial to healing. |
| Other considerations | The GDG noted that debridement methods need to be considered on an individual basis. Such consideration includes patient preference and tolerability. The GDG also identified a concern that people who are involved in the treatment of pressure ulcers do not often have the relevant experience needed to debride. Thus, any such undertaking must be done by a person who is trained and competent to ensure debridement is successful. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
| Trade off between clinical benefits and harms | Maggot therapy There was limited evidence for maggot debridement, with only 3 small cohort studies comparing maggot treatment to conservative treatment. These studies showed a clinical benefit of maggot debridement for the proportion of pressure ulcers completely healed, shorter time to healing and proportion of pressure ulcers which decreased in surface area. There was no clinical benefit for healing rate and it was unclear for change in surface area. There was no evidence for which method of maggot debridement is more effective (that is maggots in a bag compared to free-roaming maggots). The evidence used maggots that were free-roaming, with dressings to hold them in place. The GDG discussed the high cost associated with maggot debridement and that larval therapy was not considered to be cost effective (see Economic considerations). However, it was agreed that some people may benefit from the use of maggot debridement where there are contraindications to other methods of debridement (for example, those with comorbidities, where anaesthetic could be required for sharp debridement but cannot be given or where ulcers are in difficult sites) and that it may be necessary to consider the use of laval therapy in these individuals. Enzymatic debridement The evidence was very limited with a lot of uncertainty in the results. There was only 1 study found per comparison. Collagenase was found to be more clinically beneficial when compared to hydrocolloid or hydrogel dressing for complete healing compared to hydrocolloid dressing. There was no clinical benefit of collagenase for reduction in pressure ulcer size, reduction in adverse events and for time to healing when compared to hydrocolloid dressing and no clinical harm for mortality (all-cause) when compared to hydrogel or hydrocolloid dressing. Collagenase was more clinically beneficial than inactivated collagenase for proportion of ulcers that increased/decreased in size. Collagenase was more effective at improving pressure ulcers and complete healing of pressure ulcers when compared to sugar and egg white. There was no clinical benefit for collagenase compared to inactivated collagenase to reduce the odour at the end of treatment, the number of side effects or mortality. Collagenase was also more clinically beneficial than papain/urea for reduction pressure ulcers size at 4 weeks, although collagenase had higher side effects, as it did when compared to fibrinolysis/DNAse. Frequency of collagenase ointment application did not show a clinical benefit for 24 hours when compared to 48 hours for complete healing, adverse events or reducing all-cause mortality. Dextranomer was clinically more beneficial than collagenase for completely healing and improving pressure ulcers. Zinc oxide showed no clinical difference for infection, skin reaction and mortality when compared to streptokinase-streptodornase. There was no evidence comparing different techniques of debridement except for the comparison of enzymatic debridement to autolytic debridement (with the use of hydrogel or hydrocolloid dressings). Enzymatic debridement (collagenase) showed some benefit over autolytic debridement (hydrogel dressing). However the GDG noted that there were certain benefits in allowing debridement to occur naturally, as enzymatic debridement can result in the removal of tissue which might otherwise survive. The GDG felt that the use of collagenase was slower than the use of surgical debridement, and therefore surgical debridement would be preferential over enzymatic debridement. |
| Economic considerations | Maggot therapy No economic evaluations were included which assessed the cost-effectiveness of larval therapy for debridement; therefore the GDG considered relevant unit costs. The GDG noted that debridement with maggots is substantially more expensive than debridement by other means. As there was limited clinical evidence to suggest a benefit of using larval therapy, the GDG did not think that the additional cost was justified. Larval therapy is not considered to be cost-effective compared to other methods of debridement. Enzymatic debridement See recommendation 27. |
| Quality of evidence | Maggot therapy No randomised trials were found, therefore cohort studies were included in the review. The majority of outcomes came from 1 cohort study. The evidence was limited to 3 cohort studies which had very serious limitations and small sample sizes. There was no serious imprecision for the proportion of pressure ulcers decreased in surface area and healing rate. There was serious imprecision for the proportion of pressure ulcers completely healed and time to healing. The conventional treatment involved a variety of treatments including dressings, surgical and enzymatic debridement. Enzymatic debridement The evidence was weak as the studies had small sample sizes and the evidence was downgraded for serious and very serious imprecision for almost all outcomes. All the studies had very serious risk of bias. Therefore there is a lot of uncertainty in the results. The GDG noted that outcomes such as reduction in the area of pressure ulcer were sometimes difficult to interpret as debridement may increase the size of the wound whilst being beneficial to healing. |
| Other considerations | Maggot therapy The GDG noted that there can be some discomfort experienced by the individual when using maggots thus affecting tolerability of the treatment. The GDG stated that maggots were available either in a bagged form so that the maggots are contained or as free roaming maggots. Free roaming maggots are contained in the wound by a dressing put over the top. In addition, it was stated that there is at least a 1 day delay in obtaining the maggots as they cannot be stored as they need to be freshly ordered. This can be particularly problematic when wishing to obtain them over weekends and bank holidays. The GDG felt that the effectiveness of the maggots was also dependent upon the skill of the healthcare professional that uses them. It was acknowledged that the actual time taken to conduct the debridement is faster for maggot debridement than sharp debridement because maggots are quicker to apply and would require less staff time. However, both forms of debridement would require a specialist nurse. Enzymatic debridement The GDG discussed the current use of debriding agents. They informed that collagenase debridement was previously used in the UK and is used throughout the rest of the world, however it is not currently used routinely in most units. The GDG noted that in the NHS, healthcare professionals undertaking surgical debridement need to have suitable qualifications, and thus there are often limited availability for nurses to undertake this. It was therefore felt that this can increase the popularity of using enzymatic debridement methods. |
8.4.2. Neonates, infants, children and young people
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people with pressure ulcers completely healed, time to complete healing, reduction in size and volume and rate of reduction in size and volume of pressure ulcers were the most critical outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG used 2 statements from the Delphi consensus survey to help develop the recommendation on debridement in neonates, infants, children and young people. The statements were: ‘Healthcare professionals should use autolytic debridement, by the use of appropriate dressings, for the debridement of devitalized tissue in neonates, infants, children and young people’ and‘ Healthcare professionals should consider the use of sharp and surgical debridement in neonates, infants, children and young people, where autolytic debridement is insufficient.’ The statement on autolytic debridement was accepted by the Delphi consensus panel during Round 1 of the survey. The statement on surgical debridement was amended for Round 2 of the survey on the basis of comments received from the panel. The GDG discussed the comments received during Round 1, which focused on ensuring that a suitably qualified individual carried out any surgical or sharp debridement (for example a member of the surgical team or a trained tissue viability nurse). The GDG amended the statement to highlight this. The GDG felt that the statement should also be amended to highlight that autolytic debridement with appropriate dressings would be used before any sharp or surgical debridement was considered. The statement included in Round 2 of the survey was ‘Healthcare professionals should consider the use of sharp and surgical debridement by appropriately qualified staff, where autolytic debridement via the use of appropriate dressings is insufficient, in neonates, infants, children and young people.’ The statement was accepted during Round 2 of the survey. The GDG discussed the results of the survey and developed a recommendation. The GDG agreed that for some pressure ulcers (for example, those with non-viable tissue), debridement was necessary to ensure that the healing process could be completed. The GDG felt that in the majority of situations, autolytic debridement should be considered the most appropriate method of debridement as this would be achieved naturally, facilitated by the use of a dressing . Comments from the Delphi consensus panel supported this recommendation. However, the GDG acknowledged that there were some situations in which autolytic debridement was likely to be inappropriate or insufficient to remove the non-viable tissue and allow for healing of the pressure ulcer. Comments from the Delphi consensus panel supported this and highlighted that there were situations in which sharp debridement should be considered as an alternative to autolytic debridement, where this is insufficient. The GDG therefore added to the recommendation, to highlight that sharp debridement should be considered where autolytic debridement was insufficient. The GDG and Delphi consensus panel both highlighted that sharp debridement should only be carried out by an appropriate qualified healthcare professional but noted that this may vary by location. |
| Economic considerations | The GDG noted that autolytic debridement requires no additional resources over the use of an appropriate dressing, as recommended in Chapter 10. Where autolytic debridement is unsuccessful, there may be economic and clinical benefits to sharp debridement. Sharp debridement can speed up the healing process, thus reducing future treatment costs and improving quality of life. The GDG noted that there would be a small upfront cost of sharp debridement, but that this would be offset by future savings from a reduced time to healing and improvements in quality of life. |
| Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 1 of the Delphi consensus survey and reached 84% consensus agreement. A second statement was included in Round 1 of the Delphi consensus, which reached 63% consensus. This statement was amended for inclusion in Round 2 of the Delphi consensus survey, where it reached 84% consensus agreement. Further details can be found in Appendix N. |
| Other considerations | The GDG noted that recommendations on assessment to identify need for and techniques of debridement were also likely to be applicable to neonatal, infant, child and young person populations. |
- Review question: What are the most clinically and cost effective methods of debridement of non-viable tissue for the treatment of pressure ulcers?
- Maggot (larval) therapy
- Review question: What are the most clinically and cost effective methods of maggot debridement of non-viable tissue for treatment of pressure ulcers?
- Recommendations and link to evidence
- Debridement - The Prevention and Management of Pressure Ulcers in Primary and Se...Debridement - The Prevention and Management of Pressure Ulcers in Primary and Secondary Care
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