Epidermal Grafting in Wound Healing

Study Overview
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Brief Summary
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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.

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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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

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

Conditions
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Ulcer, Skin Ulcer, Wounds and Injuries

Intervention / Treatment
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* Device: Epidermal grafting
* Procedure: Split thickness skin grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidermal graft, suction blister, blister graft, suction graft, Epidermis/su, tr [Surgery, Transplantation]