A Multi-centre Randomised Controlled Trial to Compare Epidermal Grafting With Split Skin Grafting for Wound Healing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Number of Wounds With Complete Healing
Study Overview
Brief Summary
Split thickness skin grafting is the normal standard of care for wound closure. However, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that 'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This potentially results in less pain and reduced donor site morbidity but only delivers several cell layers to the wound so may be less effective at healing a wound. It is not known if EG is an effective alternative to SSG.
Further the mechanism to achieve wound healing may be different. EG promotes wound healing by expressing growth factors that accelerates wound healing and encourages keratinocyte migration. Whereas SSG is a transplant of several skin layers that integrated to the existing wound bed as a formal skin covering.
The investigators wish to compare these two clinical practises; epidermal grafting and split thickness skin grafting in wound healing. Further to undertake a translational study to investigate the mechanism by which each technique achieves wound healing.
Detailed Description
This study evaluates the efficacy of EG, as an alternative to current wound management therapy, SSG. In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site. Moreover, complete wound epithelialisation was achieved while maintaining patient independence. Therefore, this device has the potential to save healthcare resources, by eliminating the need for theatre space and a hospital bed, and result in better Patient Reported Outcomes Measures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female
- •Wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% TBSA)
- •Wound with clean, healthy granulating bed, with minimal adherent slough
- •Patient understands and is willing to participate and can comply with weekly visits and follow-up regime
Exclusion Criteria
- •Wound with active infection
- •Wound at plantar of the foot
- •Patients unsuitable for Split Skin Grafting
- •Previous history of excessive bleeding associated with surgical biopsies or trauma
- •Allergies to tegaderm (and other dressings used in the study)
- •Known uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%.
- •Presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study
- •Patient not fit for surgery (ASA classification > 4)
Arms & Interventions
Epidermal Graft
The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice.
Intervention: Epidermal grafting (Device)
Split Thickness Skin Graft
Split thickness skin graft will be harvested using air dermatome as per normal clinical practise.
Intervention: Split thickness skin grafting (Procedure)
Outcomes
Primary Outcomes
Number of Wounds With Complete Healing
Time Frame: 6 weeks and 3 months
Number of wounds with complete healing at 6 weeks
Mean Time for Donor Site Healing
Time Frame: 3 months
Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings
Secondary Outcomes
- Time for Wound Healing(3 months)
- Donor Site Morbidity(6 weeks and 3 months)
- Patient Reported Outcome Measure (PROM)(6 weeks and 3 months)
- Adverse Events(3 months)