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NCT Number: NCT02535481

Epidermal Grafting in 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.

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Key information

Conditions

Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Free Hampstead NHS Trust Hospital

London, NW3 2QG, United Kingdom

About this study

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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epidermal grafting

Device

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

Other names: CelluTome

Split thickness skin grafting

Procedure

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

Primary outcomes

  1. Number of Wounds With Complete Healing

    Time frame: 6 weeks and 3 months

    Number of wounds with complete healing at 6 weeks

  2. Mean Time for Donor Site Healing

    Time frame: 3 months

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

Secondary outcomes

  1. Time for Wound Healing

    Time frame: 3 months

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

  2. Donor Site Morbidity

    Time frame: 6 weeks and 3 months

    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.

  3. Patient Reported Outcome Measure (PROM)

    Time frame: 6 weeks and 3 months

    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.

  4. Adverse Events

    Time frame: 3 months

    Number of participants with of adverse events

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: EPIGRAAFT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2015
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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