Comparison of cleaning of leg ulcers using pads or wound dressings

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2012
INTERVENTION: Treatment arm: Debrisoft® (Activa Healthcare) consists of monofilament polyester fibres, the reverse side is coated with polyacrylate. The product is individually packed and sterile (heat treated). Debrisoft® is for single use only and must not be re‐sterilized. The product is sterile as long as the packaging remains unopened and undamaged. Indications: In wound bed preparation, Debrisoft® is intended as a rapid, highly effective and safe debridement method in the treatment of superficial wounds and their surrounding skin, for example in cases of diabetic ulcers, arterial and venous ulcers, pressure ulcers and postoperative wounds healing by second intention Debrisoft® can also be used for absorbing exudate, cellular debris and keratosis during debridement. Debrisoft® is gentle on intact tissue. There are also very good results with Debrisoft® in the treatment of wounds with major keratotic and necrotic coatings, provided these wounds have previously been treated with autolytic debridement [8, 11]. Application: 1. Remove the existing wound dressing. 2. Debridement procedure: 2.1. Soak Debrisoft® with e.g. water or saline, according to local guidelines. 2.2. Wipe the wound surface gently with the soft fibre side of the moistened Debrisoft® (without any extensive pressure). 3. Repeat the procedure with a fresh Debrisoft® to cleanse the peri ulcer skin and any areas of the lower limb covered with hyperkeratosis. 4. Apply emollient if required to the peri ulcer skin and lower limb. 5. Apply a new wound dressing. Precautions: Debrisoft® must not be used as a wound dressing. The product must not be used in case of known intolerance or an allergy against one or more of its constituents. Control arm: Intrasite Conformable (Smith & Nephew Healthcare) is a hydrogel wound dressing consisting of a non‐woven dressing wilh a clear amorphous hydrogel. The hydrogel contains a modified carboxy‐methyl cellulose polymer, propylene glycol and water. Mode of action: Intr CONDITION: Leg ulcer, chronic wound ; Skin and Connective Tissue Diseases ; Ulcer of lower limb, not elsewhere classified PRIMARY OUTCOME: 1. To compare the performance of two debridement methods upon ; 1.1. Changes in the appearance of the wound bed will be based upon quantitative size and colour analysis of photographs taken before debridement and ten 10 minutes after debridement has occurred with these measures repeated weekly for 2 weeks.; 1.2. The wound size within 14 days of treatment SECONDARY OUTCOME: 1. The removal of hyperkeratosis; 2. The relative costs of each treatment option ; 3. Narrative reports from clinical staff and subjects regarding their experience of the two interventions; 4. Any pain and discomfort associated with the use of the interventions rated using visual analogue scales INCLUSION CRITERIA: 1. Age: At least 18 years of age 2. Sex: Males and females (provided they are not pregnant) 3. Patients with a leg ulcer (surface area no larger than 40cm^2) of any aetiology and not older than one year. Leg ulcer at least 50% covered with devitalised tissue that is not fixed dry necrotic tissue or tenacious slough. 4. The patient is able to understand the trial and is willing to give written consent to the trial
Epistemonikos ID: cba5852f58d35cb9a70c39682f33d49ac25a1e2c
First added on: Aug 22, 2024