Epidermal Grafting in Wound Healing (EPIGRAAFT)

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

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 Overview

• Status: Completed
• Conditions: Wounds and Injuries; Ulcer; Skin Ulcer
• Intervention / Treatment: Device: Epidermal grafting; Procedure: Split thickness skin grafting

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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hampstead NHS Trust Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female
2. Age 18-90
3. Wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% TBSA)
4. Wound with clean, healthy granulating bed, with minimal adherent slough
5. Patient understands and is willing to participate and can comply with weekly visits and follow-up regime

Exclusion Criteria:

1. Wound with active infection
2. Wound at plantar of the foot
3. Patients unsuitable for Split Skin Grafting
4. Previous history of excessive bleeding associated with surgical biopsies or trauma
5. Allergies to tegaderm (and other dressings used in the study)
6. Known uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%.
7. 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
8. Patient not fit for surgery (ASA classification > 4)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidermal Graft; The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice.	Device: Epidermal grafting; The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts.; Other Names: CelluTome
Experimental: Split Thickness Skin Graft; Split thickness skin graft will be harvested using air dermatome as per normal clinical practise.	Procedure: Split thickness skin grafting; Split thickness skin grafting will be performed as per normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for Wound Healing	Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings	3 months
Donor Site Morbidity	The donor site morbidity was measured using the Vancouver Scar Scale (VSS). Total score scale ranges from 0 to 13. Lower score is more desirable as it represents a scar resembling normal surrounding skin. The scale assesses 4 categories: vascularity, height, pliability, and pigmentation. Total score is obtained by the sum of the categories.	6 weeks and 3 months
Patient Reported Outcome Measure (PROM)	Patient reported outcome measure was assessed using a validated skin graft satisfaction questionnaire.The skin graft satisfaction questionnaire has a scale ranging from 1 to 7, with 1 representing very unsatisfied while 7 represents very satisfied. Hence, higher score represent higher satisfaction.	6 weeks and 3 months
Adverse Events	Number of participants with of adverse events	3 months

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Toby Richards, MD FRCS, University College, London; Principal Investigator: Afshin Mosahebi, MBBS FRCS PhD MBA, Royal Free Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: suction blister; epidermal graft; blister graft; suction graft; Epidermis/su, tr [Surgery, Transplantation]
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Ulcer; Wounds and Injuries; Skin Ulcer
• Other Study ID Numbers: 15/0079