Epidermal Grafting in Wound Healing

NCT ID: NCT02535481

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-11-30

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.

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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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

Conditions

Ulcer; Skin Ulcer; Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epidermal Graft

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

Group Type: EXPERIMENTAL

Epidermal grafting

Intervention Type: DEVICE

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

Split Thickness Skin Graft

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

Group Type: EXPERIMENTAL

Split thickness skin grafting

Intervention Type: PROCEDURE

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

Interventions

Epidermal grafting

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

Intervention Type: DEVICE

Split thickness skin grafting

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

Intervention Type: PROCEDURE

Other Intervention Names

CelluTome

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toby Richards, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University College, London

Afshin Mosahebi, MBBS FRCS PhD MBA

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

Locations

Royal Free Hampstead NHS Trust Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32532631 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27185033 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15/0079

Identifier Type: -

Identifier Source: org_study_id