Epidermal Grafting in Wound Healing

Wounds and Injuries Clinical Trial

— EPIGRAAFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535481
• Other study ID #: 15/0079
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2017

Study information

• Verified date: July 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Skin Ulcer
• Ulcer
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Free Hampstead NHS Trust Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Wounds With Complete Healing	Number of wounds with complete healing at 6 weeks	6 weeks and 3 months
Primary	Mean Time for Donor Site Healing	Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings	3 months
Secondary	Time for Wound Healing	Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings	3 months
Secondary	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
Secondary	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
Secondary	Adverse Events	Number of participants with of adverse events	3 months