Cultured keratinocytes in burn wound care
| ISRCTN | ISRCTN63305738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63305738 |
| Secondary identifying numbers | v3 020911 revised 120412 |
- Submission date
- 10/06/2012
- Registration date
- 25/06/2012
- Last edited
- 06/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and Study Aims
We are recruiting up to 10 patients with severe burns to compare two different cell based approaches to help heal their wounds in an initial study. Our aim is to compare a treatment using donor skin cells with a treatment using the patients own cells. We want to compare the rates of wound closure using these two approaches, and to demonstrate that both approaches are safe. The study findings will inform future approaches to burn wound care, and may be applicable to chronic wounds also.
Who can participate
Man and women over the age of 18 who have been injured by chemical or thermal burns may participate in the study. These patients will usually require a skin graft to help heal the burnt areas.
What does the study involve
Over a period of up to two years, patients with severe burns who require a skin graft as part of their treatment will be eligible for a cell based intervention. Patients will donate a 2x2cm skin biopsy of thickness of about 0.6mm for preparation into a treatment called ReCell. This is a cell suspension derived from the patients own skin cells. These will be sprayed onto a selected area of the burn wound. In addition, a cell suspension manufactured from an accredited donor skin cell bank (Cryospray) will be applied to a separate area of the same burn wound. These two active treatment areas will be compared with a control area which receives standard care (inert dressings). One application of cells, both autologous (patients own) and allogeneic (donor) will be applied to the burn wound, and the areas will be observed at days 2, 5-7, 10 and 16. Small punch biopsies of selected treatment areas will be taken at day 0, 2 and 5-7 to identify cells responsible for healing.
What are the possible benefits and risks of participating?
There is a possible direct benefit of taking part which is that burn areas treated with cells will show accelerated healing compared to those treated with standard care. Faster wound closure can be associated with reduction in pain, reduced risk of infection and improved aesthetic and functional outcome. There should be benefits to treating future burns patients, who have relatively few effective therapies available to them. Furthermore the findings could help treatment approaches for patients with chronic skin wounds such as diabetic ulcers or venous ulcers, which affect many thousands of people in the UK and worldwide. There is a small risk of scarring from taking a skin biopsy for the ReCell treatment, but the biopsy is not full thickness, and the wound site will be expected to heal naturally in about 12 days. Participants will provide small biopsies of healed areas these will be taken from sites selected to provide minimum discomfort and aesthetic impact, although both considerations are minor compared to the trauma associated with the initial burn injury.
Where is the study run from?
The study is set up by Queen Mary University, London, and will take place at the St Andrews Centre for Burns and Plastic Surgery, Broomfield Hospital, Chelmsford.
When is the study starting and how long is it expected to run for?
Recruitment is expected to start in July 21012. Participants will be treated for up to 17 days but will be enrolled for a period of 24 weeks to allow long term follow up of wound closure. The study will run for up to two years.
Who is funding the study?
Funding is provided by Queen Mary University, London as part of a Technology Strategy Board (TSB) regenerative medicine award. The TSB is a UK government body tasked with fostering UK innovation in priority growth areas.
Who is the main contact?
Mr Simon Myers
S.myers@qmul.ac.uk
Contact information
Scientific
Queen Mary University London
Blizzard Institute
Mile End Road
London
E1 4NS
United Kingdom
Study information
| Study design | Non-randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Cultured keratinocytes in burn wound care: a non-randomised study |
| Study objectives | Cultured allogeneic keratinocytes are capapble of accelerating wound closure at least as well as autologous keratinocyte suspensions |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Severe burns - acute |
| Intervention | This is an intra-patient study (each patient will act as their own control) and each patient will receive all the treatment regimes under investigation i.e. Cryopsray, ReCell and standard care. Standard care - grafting and inert bandages. Active group 1 - cultured allogeneic keratinocytes (Cryospray) + standard care Active group 2 - autologous keratinocyte suspension (ReCell) + standard care |
| Intervention type | Other |
| Primary outcome measure | Objective measures of wound healing via punch biopsy analysis (time course of cytokine and growth factor expression) |
| Secondary outcome measures | 1. Time to complete wound closure (100% re-epithelialisation) 2. Aesthetic outcome of burn site via Derriford Appearance Scale and Patient and Observer Scar Assessment Scale (POSAS) at week 4, 8, 12 and 24 |
| Overall study start date | 01/07/2012 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Up to 10 |
| Key inclusion criteria | 1. Patients who are 18 years old at least 2. Patient is in good general health 3. Patient is willing and able to co-operate with the protocol for the duration of the study 4. Patients with a donor graft site due to requiring a split skin graft to treat a large burn 5. Patients able to give written consent |
| Key exclusion criteria | 1. Patients unable to give written consent 2. Terminally ill patients 3. Pregnant women 4. Patients with skin disorders that may affect the growth of cells or subsequent wound healing e.g. patients on high concentrations of steroids, patients with psoriasis or eczema 6. Patient has a history of hypersensitivity to any components of either Cryoskin Spray (e.g. DMSO) or ReCell (trypsin) 7. Patients with eczema; genetic skin conditions; hypertrophic or keloid scars |
| Date of first enrolment | 01/07/2012 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
E1 4NS
United Kingdom
Sponsor information
University/education
c/o Mr. Simon Myers
Centre for Cutaneous Research
Blizard Institute
4 Newark Street
London
E1 2AT
England
United Kingdom
"ROR" |
https://ror.org/026zzn846 |
|---|
Funders
Funder type
Government
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
06/12/2016: No publications found in PubMed, verifying study status with principal investigator.
