N/A
N=44
Epidermal Grafting in Wound Healing
Ulcer · Skin Ulcer · Wounds and Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02535481 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Wounds With Complete Healing — 9; 13; 16; 20 number of wounds — p=0.366
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Epidermal grafting (Device); Split thickness skin grafting (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University College, London
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Wounds With Complete Healing |
9; 13; 16; 20 | 0.366 |
| PRIMARY Mean Time for Donor Site Healing |
4.86; 21.32 | <0.0001 sig |
| SECONDARY Time for Wound Healing |
7.81; 6.59 | 0.12 |
| SECONDARY Donor Site Morbidity |
0.14; 3.73; 0.09; 2.91 | 0.001 sig |
| SECONDARY Patient Reported Outcome Measure (PROM) |
7; 6; 7; 6 | 0.001 sig |
| SECONDARY Adverse Events |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female
- Age 18-90
- 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)
Data sourced from ClinicalTrials.gov (NCT02535481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.