CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Epidermal grafting +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02535481
NCT02535481N/ACompleted

A Multi-centre Randomised Controlled Trial to Compare Epidermal Grafting With Split Skin Grafting for Wound Healing

University College, London·interventional·Posted Aug 28, 2015·Updated Aug 10, 2020

In Brief

A clinical study evaluating Epidermal grafting and Split thickness skin grafting for Ulcer and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 28, 2015
Enrollment StartOct 1, 2015
Primary CompletionAug 1, 2017
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.8 years ago

Interventions

Epidermal graftingdevice

The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts.

Split thickness skin graftingprocedure

Split thickness skin grafting will be performed as per normal clinical practice.