Epidermal Grafting in Wound Healing

NCT02535481 | Completed Results DMC

• 1 other identifier: 15/0079
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer; Skin Ulcer; Wounds and Injuries

Keywords

epidermal graft; suction blister; blister graft; suction graft; Epidermis/su, tr [Surgery, Transplantation]

Outcome Measures

Primary Outcomes (2)

• Number of Wounds With Complete Healing

  Number of wounds with complete healing at 6 weeks

  6 weeks and 3 months

• Mean Time for Donor Site Healing

  Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings

  3 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Epidermal Graft

EXPERIMENTAL

The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice.

Device: Epidermal grafting

Split Thickness Skin Graft

EXPERIMENTAL

Split thickness skin graft will be harvested using air dermatome as per normal clinical practise.

Procedure: Split thickness skin grafting

Interventions

Epidermal grafting DEVICE

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

Also known as: CelluTome

Epidermal Graft

Split thickness skin grafting PROCEDURE

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

Split Thickness Skin Graft

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hampstead NHS Trust Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• Kanapathy M, Bystrzonowski N, Hachach-Haram N, Twyman L, Becker DL, Richards T, Mosahebi A. Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial). J Plast Reconstr Aesthet Surg. 2020 Aug;73(8):1556-1564. doi: 10.1016/j.bjps.2020.03.006. Epub 2020 Mar 16.

  PMID: 32532631 DERIVED

• Kanapathy M, Hachach-Haram N, Bystrzonowski N, Harding K, Mosahebi A, Richards T. Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial. Trials. 2016 May 17;17(1):245. doi: 10.1186/s13063-016-1352-y.

  PMID: 27185033 DERIVED

MeSH Terms

Conditions

Ulcer; Skin Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: EPIGRAAFT Trial team
• Organization: UCL

epigraaft@gmail.com

020 7679 2000

Study Officials

• Toby Richards, MD FRCS

  University College, London

  PRINCIPAL INVESTIGATOR

• Afshin Mosahebi, MBBS FRCS PhD MBA

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 28, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 10, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-07

Locations

GB (1)