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Epidermal Grafting in Wound Healing

NCT02535481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-08-10

Study results available
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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.

Conditions

  • Ulcer
  • Skin Ulcer
  • Wounds and Injuries

Interventions

DEVICE

Epidermal grafting

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

PROCEDURE

Split thickness skin grafting

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Toby Richards, MD FRCS · University College, London

  • Afshin Mosahebi, MBBS FRCS PhD MBA · Royal Free Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-08-31
Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535481 on ClinicalTrials.gov