3 Clinical evidence

3 Clinical evidence

Summary of clinical evidence

3.1 Full details of all clinical outcomes considered by the Committee are available in the assessment report overview.

3.2 The key clinical outcomes for the Debrisoft monofilament debridement pad presented in the decision problem were:

  • pain and discomfort for the patient when debriding the wound

  • wound malodour

  • time to complete debridement

  • time to healing

  • wound infection/cellulitis

  • the number, frequency and duration of healthcare professional (nurse) visits for each patient

  • the number of debridements needed

  • device-related adverse events, including non-selective trauma to healthy surrounding tissue or bleeding.

3.3 The clinical evidence for the Debrisoft pad was based on 15 multiple-patient case-series reports (5 peer-reviewed papers and 10 posters), some of which included retrospective comparators. There were no randomised controlled trials. The External Assessment Centre considered that 7 studies (Bahr et al. 2011; Callaghan and Stephen-Haynes, 2012; Collarte et al. 2011; Johnson et al. 2012a; Mustafi et al. 2011; Pietroletti et al. 2012; Wiser et al. 2012) were directly relevant to the scope because they included appropriate comparators and outcomes. Two of the papers (Bahr et al. 2011; Mustafi et al. 2011) presented results from the same study.

Multiple patient case-series: peer-reviewed papers

3.4 Bahr et al. (2011) and Mustafi et al. (2011) compared the overall mean time of each debridement session, using the Debrisoft pad, with hydrogel, gauze and surgical debridement in 60 patients. In minutes, this was 2.51 (SD±0.57) for Debrisoft, 7 (±2.08) for hydrogel, 5 (±1.60) for gauze and 9 (±2.64) for surgical debridement. Complete debridement was achieved in 77% (n=44) of patients using the Debrisoft pad in 12 days compared with an estimate taken from the literature of approximately 20 days for enzymes or hydrogel. Using a 6-point scale (1=excellent to 6=inadequate), Debrisoft users rated its debridement efficacy as 'very good', giving a mean score of 1.98 (±0.68) compared with hydrogel, which scored 2.54 (±0.72). The convenience and ease of use of the Debrisoft pad was rated 'very good' by its users, with a mean score of 2.29 (±0.57) on the 6-point scale. Wet gauze was rated similarly with a mean score of 2.49 (±0.67). When using the Debrisoft pad, there was a significant improvement in wound bed condition after 3 debridement sessions. After 1 session, 60% of wounds (n=34) were categorised as covered in slough with some necrotic tissue, after 3 sessions this was 47% (n=27). After 1 session 28% of wounds (n=16) were categorised as covered in slough with no necrotic tissue, after 3 sessions this was 25% (n=14). After 1 session 12% of wounds (n=7) were clean with less than 20% slough, after 3 sessions this was 7% (n=4). Twenty-one per cent (n=12) of wounds had re-epithelialised. Debridement was effective in 93.4% (142/152) of the sessions. During the debridement procedure 45% (n=26) of patients reported that they experienced no pain, 50.4% (n=29) reported slight discomfort of short duration (mean 2 minutes) and 4.6% (n=2) reported moderate pain of short duration (mean 2.4 minutes). No side effects after the procedure were reported by 56 out of 57 patients. No serious adverse events or adverse events were reported. Clinicians reported that the Debrisoft pad removed debris, slough, dried exudate and crusts efficiently, without damaging the fragile skin surrounding the wound. Photographic analysis confirmed this.

3.5 Gray et al. (2011) described a case series of 18 patients that evaluated which types of slough and necrotic tissue benefit most from debridement with the Debrisoft pad. One patient was unable to tolerate the use of the pad. Results were reported for 10 patients only. Two patients had hyperkeratotic skin removed on their lower limb in less than 2 minutes. One patient's hyperkeratotic skin was not removed by the Debrisoft pad, but it was thought that this was because an emollient was applied before the treatment. Two patients had their wound beds cleared of any haematoma after it had been debrided for less than 5 minutes. One patient had most (not specified how much) of their haematoma cleared from the wound bed. Two patients with pressure wounds on the heel were reported as having partially successful debridement (not clear how successful). Sloughy leg ulcers in 2 patients were fully debrided. The authors noted that when dry, black necrosis or slough had adhered to the wound bed, the Debrisoft pad did not remove the devitalised tissue.

3.6 Hammerle et al. (2011) described a case series of 11 patients with chronic wounds from 2 hospitals. The Debrisoft pad was able to remove most of the coatings in exudating, seropurulent wounds with highly viscous yellow slough (indicating local infection) after a single use. Most of the material removed by debridement became attached to the pad. In dry wounds with serocrusts between the new vital granulation and epithelial tissue, the Debrisoft pad was able to remove the crusts without affecting the new healthy tissue. In wounds with necrotic layers, hyperkeratotic debris and crusts of dried exudate, the Debrisoft pad removed the necrotic layers after a single use and revealed the skin of the lower extremity, showing an almost normal epidermis. For both types of wound, the Debrisoft pad was able to debride without affecting the new healthy tissue, which was undisturbed by the debridement process.

3.7 Johnson et al. (2012a) described a 2-centre observational study that compared the effectiveness of the Debrisoft pad with other non-specified debridement methods. Ten patients were recruited from each centre. Although it was not stated explicitly, it appears from the results that each wound was treated once using the Debrisoft pad. Patients found the treatment very acceptable with minimal pain reported in 95% of cases. The reported time to debridement was 2–4 minutes for 10 patients, 5–7 minutes for 5 patients and more than 7 minutes for 5 patients. Skin condition after Debrisoft pad use compared with a previous hyperkeratosis method was rated for 8 patients and was 'much better' for 6 patients, 'good' for 1 patient and 'very good' for 1 patient. Debridement performance compared with a previous method was rated for 16 patients by the clinician and was 'much better' for 8 patients, 'good' for 5 and 'very good' for 3.

3.8 Stephen-Haynes and Callaghan (2012) evaluated the use of the Debrisoft pad by 40 tissue viability nurses, over a 12-week period, on a wound or hyperkeratosis. The Debrisoft pad was used for wound debridement by 25 nurses (62.5%), for hyperkeratosis by 4 nurses (10%), and for both by 11 nurses (27.5%). Thirty-eight of the nurses (95%) said that patients' skin condition improved, whereas 2 (5%) said that it remained the same. Thirty-two of the nurses (80%) reported a positive impact on the wound bed using visual assessment. Thirty-four nurses (85%) reported that after debridement, there was clearer visibility of the wound bed and surrounding skin because of the removal of debris, slough or hyperkeratosis, so they were able to identify clearer wound management objectives. Six out of 40 nurses (15%) said there was no improvement. The time taken to carry out debridement using the Debrisoft pad was 0–2 minutes in 8 patients (20%); 3–5 minutes in 21 patients (52.5%) and 6–10 minutes in 9 patients (22.5%). The overall performance of the Debrisoft pad was rated as 'very good' by 24 nurses (60%), 'good' by 10 nurses (25%), 'fairly good' by 5 nurses (12.5%) and 'poor' by 1 nurse (2.5%).

Multiple patient case-series: posters

3.9 Albas (2012) evaluated the Debrisoft pad for 10 patients with trauma wounds and bites. Debridement was considered effective in all patients because visible debris and slough were successfully removed. A mean of 2.1 sessions (SD±0.83; range: 1–3) was needed to obtain a clean wound bed. In all sessions, the product remained intact. The mean time for the debridement sessions was 2.57 minutes (SD±0.04; range 2–4). Patients reported slight discomfort for a short duration (2 minutes on average) in 35% of cases and no discomfort in 65% of cases. No secondary infections were reported.

3.10 Callaghan and Stephen-Haynes (2012) described a case series of 12 patients with pressure ulcers. The time to achieve debridement was 0–5 minutes in all 12 patients. Four patients had pain during the procedure (visual analogue scale [VAS]: 1, 1, 6, 4) but the first 3 of these patients had pain before treatment started (VAS: 1, 1, 7). No patients reported pain after treatment. There was improved visualisation of the wound bed in 92% (11/12) of the patients. Treatment using the Debrisoft pad reduced wound care visits in 92% (11/12) of the patients. The treatment helped assess the category of pressure ulcer in all 12 patients.

3.11 Collarte et al. (2011) evaluated the use of the Debrisoft pad in 10 patients and reported that it was easy to use and removed devitalised tissue and hyperkeratosis more quickly compared with standard treatment. The time to treat was decreased and patients found the treatment to be comfortable. One patient had a venous leg ulcer debrided in 4 minutes using the Debrisoft pad, with no reported pain or discomfort. Previously nurses had attempted to debride the wound with autolytic therapy and larvae, but with limited success.

3.12 Dam (2012) evaluated the Debrisoft pad in 29 patients with chronic wounds. On average, fibrin was reduced by 30%. It was reported that thin and soft layers of fibrin were easier to remove than thick fibrin and necrotic tissue. The Debrisoft pad was not able to remove fibrin that had firmly adhered to the wound bed. Topical analgesia was used in 11 patients; 8 patients reported no change in pain level and 10 patients reported increased pain during debridement. Keratosis was present in 21 patients and this was removed by the Debrisoft pad in all 21 patients.

3.13 Johnson (2012b) described a case series in which the Debrisoft pad facilitated healing in all 10 patients. It was stated that pain scores remained low during debridement, with most patients scoring the same before, during and after the procedure. The average debridement time was 4 minutes (range 2–10). The time to complete healing was recorded as between 2 weeks for 2 patients with venous leg ulcers and 6 weeks for 2 patients with mixed aetiology. The wound of 1 patient treated before a below knee amputation healed with no complications but it was not stated how long this took. The wounds of 2 other patients did not heal before the end of the 12 weeks and 1 patient was lost to follow-up.

3.14 Pietroletti et al. (2012) assessed the efficacy of the Debrisoft pad in a case series of 27 patients. The data were retrospectively compared with a group of 25 patients who had used an autolytic debridement method of either hydrogel or enzymes. The wound condition in both groups was wound bed coated with fibrin and slough or skin around the wound with keratosis and/or exudate. The maximum area of the wounds was 60 cm2. Results showed that 92% of patients had their wound debrided after 1 application of the Debrisoft pad. This involved 1 visit, whereas 38.4% of patients had debrided wounds after 1 application of the autolytic or enzymatic debridement, which involved 2 visits. The author concluded that based on these results, autolytic debridement would need to be used 8 to 10 times to achieve the same results as the Debrisoft pad.

3.15 Rieke (2012) reported the results of an observational study of 25 patients in which the Debrisoft pad was used on diabetic foot ulcers. Debridement was effective in all of the sessions and visible debris, slough, hyperkeratosis and scabs were successfully removed. In 8 cases additional surgical debridement was performed to remove the thick callus at the edges. The mean time for each debridement session was 2.59 minutes (±SD 0.06). Eighteen of the 25 ulcers healed within 16 weeks (study end point), 2 needed surgery and 5 did not heal.

3.16 Skovgaard-Holm and Simonsens (2012) described a study of 10 patients that was completed by homecare nurses. Debridement using the Debrisoft pad was performed 3 times a week over a 2-week period. The efficacy rate of the Debrisoft pad was found to depend on the thickness and adherence of the slough and the thickness of the hyperkeratotic layer. Debridement reduced the area of thin slough by an average of 24% in 3 patients. In 6 patients, an adherence layer of slough was reduced by an average of 7%. The Debrisoft pad reduced a thick soft layer of slough by 10% in 1 patient. Three patients did not feel increased pain during treatment, but 3 experienced severe pain (VAS scores of 8, 7 and 6). The pain level decreased immediately after treatment to the level at the starting point. The nurses felt that 4 patients would have benefitted from local anaesthesia before treatment.

3.17 Wiser et al. (2012) retrospectively compared the debridement results using the Debrisoft pad in 15 patients with venous leg ulcers or diabetic foot ulcers with a sloughy wound bed with the results obtained with saline soaks used in a similar patient group. No quantitative results were reported. The Debrisoft pad was shown to deliver effective and fast debridement, but it was reported to be somewhat rigid when used on toes or cavity wounds. Patient-reported pain during the procedure was less than for those treated with saline soaks, especially for the patients with arterial ulcers. The slight discomfort reported with the Debrisoft pad seemed to be better tolerated than debridement using saline soaks. Use of the product did not cause damage to the fragile skin surrounding the wound.

Adverse events

3.18 No adverse event reports relating to the Debrisoft pad were reported in a search of the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. The Medicines and Healthcare products Regulatory Agency (MHRA) has not received any reports of adverse events relating to the Debrisoft pad.

Committee considerations

3.19 The Committee noted that the clinical evidence base for the Debrisoft pad was limited to 15 studies with 10 of these coming from poster presentations. The Committee agreed with the External Assessment Centre's conclusions that there was a lack of good quality comparative evidence. The Committee recognised that the lack of this type of evidence is common in woundcare management, and it would encourage the collection of better quality comparative evidence to improve decision-making in the debridement of acute or chronic wounds.

3.20 The Committee considered that the studies provided evidence that the Debrisoft pad was safe to use for wound debridement and in some cases had equal or greater efficacy than the comparators. Using expert advice and the available evidence the Committee judged that the Debrisoft pad was likely to completely debride appropriate wounds more quickly than gauze and hydrogel. The Committee accepted that quicker debridement may give earlier visibility of the wound bed and therefore enable better management of the wound. In addition, the Committee considered that the Debrisoft pad was convenient and easy to use, and was well tolerated by patients.

3.21 The Committee considered that there was evidence of efficacy for the use of the Debrisoft pad on sloughy wounds with exudate and hyperkeratotic skin. It noted from the clinical evidence and expert advice that the Debrisoft pad may not be as effective on wounds in which black necrosis or slough had adhered to the wound bed. The Committee considered that little evidence was presented that was specific to use on acute wounds or to the treatment of children. The Committee concluded that appropriate wound selection is important for the use of the Debrisoft pad.

3.22 The Committee noted that NICE clinical guidelines support wound debridement, but that the clinical pathway may vary for different types of wounds. The Committee accepted expert advice that hydrogel and larvae are the most appropriate comparators currently used in the community for the same type of wounds as the Debrisoft pad. The Committee considered that the role of gauze in clinical practice is particularly unclear, but it received expert advice that gauze is unlikely to be used to debride a wound in UK clinical practice, because its use is painful for the patient.

3.23 The Committee received expert clinical advice that the use of larvae is a valid comparator because they are now provided in bags and are regularly used in community wound management.

  • National Institute for Health and Care Excellence (NICE)