Comparison of cleaning of leg ulcers using pads or wound dressings
| ISRCTN | ISRCTN47349949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47349949 |
| Secondary identifying numbers | 8.0 |
- Submission date
- 14/06/2012
- Registration date
- 10/07/2012
- Last edited
- 28/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
We are carrying out a study of 66 people with leg ulcers that require to have their wounds cleaned to remove loose dead tissue to allow healing to begin. The aim of the study is to compare the ease of cleaning wounds with either a wound dressing or a monofilament fibre pad.
Who can participate?
The study aims to recruit about 66 people aged over 18 years old and who have a leg ulcer treated within a leg clinic, Leg Club or at home.
What does the study involve?
Over a period of two weeks participants will be invited to have their leg ulcer cleaned either with a wound dressing or a monofilament fibre pad. Each participant will have their leg ulcer cleaned at weekly intervals with the ulcer photographed before and after each time the wound is cleaned. You will be asked to rate the comfort and any pain associated with the cleaning of your wound each time the wound is cleaned. Whether your wound is cleaned with a wound dressing or a fibre pad will be decided by a process called randomisation, which is like a coin toss.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. However for people who have leg ulcers in the future they may receive benefits in terms of quicker cleaning of their leg ulcer. If you have loose dead tissue within your leg ulcer your nurse will clean this away to allow healing to begin, as such there is no risk involved in participating in the study as you would receive wound cleaning whether or not you participate in the study.
Where is the study run from?
The study has been set up by two investigators well experienced in wound healing and will take place in Cardiff.
When is study starting and how long is it expected to run for?
It is anticipated that recruitment will start late in 2012. Participants will be enrolled on the study for a period of two weeks so it is anticipated that the study will end in mid 2013.
Who is funding the study?
Activa Healthcare Ltd, a UK company who manufacture one of the products to be used to clean your leg ulcer.
Who is the main contact?
Chief investigator's:
Professor Michael Clark, reachmichaelclark@gmail.com
Ms Trudie Young, reachtrudieyoung@gmail.com
Contact information
Scientific
Creative Consultancy & Research
237 Capella House
Cardiff
CF10 4RE
United Kingdom
Study information
| Study design | Prospective open label randomised controlled exploratory trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective, randomised controlled exploratory study comparing the debridement of sloughy venous leg ulcers undertaking either with a novel debriding agent (monofilament fibre pad) or autolytic debridement using wound dressings |
| Study hypothesis | The study will be a prospective, open label randomised controlled, exploratory trial to compare the performance of two techniques used to debride wounds (Debrisoft® debrider and autolytic debridement achieved through the use of wound dressings that maintain a moist environment at the wound surface). |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Leg ulcer, chronic wound |
| 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: Intrasite Conformable promotes natural debrIdement through autolysis by gently rehydrating necrotic tissue. It also loosens and absorbs slough and exudate. Intrasite Conformable provides a moist wound environment. It does not harm viable tissue or skIn surrounding wounds. lntrasite Conformable faciltates the gentle packing of cavity wounds to allow them to heal from the base, as well as aidIng application of gel to awkward areas. Indications: Intrasite Conformable Is indicated for use In open wounds e.g. pressure ulcers, surgical wounds healing by secondary Intention, malignant wounds, shallow wounds, excorIated skin and radiation burns. Application: For shallow wounds, apply at least two layers of the dresslng: Ensure res!dual gel Is removed prior to radiation therapy. 1. Clean the wound with sterile saline solution. 2. Apply the dressIng as required to loosely fill or cover the wound. 3. Cover with a secondary dressing e.g. film dressing or absorbent dressing. 4. To change the dressing, sImply remove gently with forceps and irrigate the wound with sterile saline. Ensure that all dressIngs are removed. It Is recommended that the dressing Is changed at least every three days. Precautions Known sensitivity to Intrasite Conformable or any of Its Ingredients. Intrasite Conformable should be used with care in the vicinity of the eyes. AvoId Ingestion. Avoid use on cracked nIpples. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/10/2012 |
| Overall study end date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 66 |
| Participant 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 |
| Participant exclusion criteria | 1. Leg ulcer larger than 40cm^2 and older than one year 2. Leg ulcer covered by fixed dry necrotic tissue or tenacious slough 3. Leg ulcer not covered to 50% of its surface area with devitalised tissue (slough) 4. Known allergy to components of the Debrisoft® debrider or wound dressing 5. Use of the debrider is too painful and patient cannot tolerate its mechanical action 6. Malignant wound 7. Recent deep venous thrombosis or venous surgery 8. Progressive neoplastic lesion treated by radiotherapy or chemotherapy 9. Prolonged treatment with immunosuppressive agents or high dose corticosteroids 10. Patients who have participated in this trial previously 11. Patients who have participated in a pharmacological clinical trial within the past six months 12. Patients who are unable to understand the aims and objectives of the trial 13. Patients with a known history of non concordance with medical treatment 14. Females who are pregnant |
| Recruitment start date | 01/10/2012 |
| Recruitment end date | 31/03/2013 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
CF10 4RE
United Kingdom
Sponsor information
Industry
1 Lancaster Park
Burton-on-Trent
DE13 9PD
United Kingdom
| Website | http://www.activahealthcare.co.uk/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/01/2016: No publications found on PubMed.
28/02/2018: No publications found.
