Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting

Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting: A Prospective Half-side Comparative Study

Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration.

There is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity.

Small portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance

Study Overview

• Status: Recruiting
• Conditions: Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts
• Intervention / Treatment: Procedure: Minced skin grafts for donor site

Detailed Description

The aim of this study is to compare the duration of wound healing, scar quality and cosmetic results of donor sites after split-thickness skin grafting with and without the use of residual graft pieces as minced skin grafts.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Abd Elmawla Mohamed, Resident plastic surgeon; Phone Number: +0201221953861; Email: mohamed_abdelmageed@med.sohag.edu.eg
• Study Contact Backup: Name: Gamal Yousef Elsayed, Professor of plastic surgery; Phone Number: +20 115 6996929

Study Locations

• Egypt
  • Sohag, Egypt, 02093
    • Recruiting
    • Plastic surgery department, Faculty of medicine, Sohag university
    • Contact: Gamal Yousef Elsayed, Professor of plastic surgery; Phone Number: +20 115 6996929
    • Contact: Mohamed Abd El-Mawla Mohamed, Resident plastic surgeon; Phone Number: +0201221953861; Email: mohamed_abdelmageed@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients undergoing split-thickness skin grafting, between 12 - 60 years of age.

Exclusion Criteria:

• Patients under the age of 12 years or above 60 years.
• Patients with a known tendency for hypertrophic scarring/keloids
• Pregnancy
• Co-morbid factors such as uncontrolled diabetes, ischemic heart disease, renal failure or Collagen vascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cases; A Prospective Half-side Comparative Study, Minced skin grafts will be used on a half of donor site of the same patient

Procedure: Minced skin grafts for donor site; After harvesting of STSG using watson's knife and coverage of the recipient site, the excess graft edges will be trimmed and together with any unused graft pieces will be collected in saline filled plate to prevent graft dissecation. Graft pieces will be placed over a rigid surface such as dorsum of a stainless steal jar or pot. Mincing of these small grafts will be done manually using large blade (no. 25) and sharp scissors. The resulting pasty graft mass composed of a large number of minced skin graft particles and a small amount of saline solution will be spread onto one half of the donor site using small dressing forceps. Minced skin grafts will not be used on the other half (control side). The entire donor site will be covered with non-adherent absorbable dressing in the form of Vaseline gauze and sterilized cotton-filled dressing followed by elastic compression bandage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar quality	using POSAS scale. • Patient Observer Scar Assesment Scale (POSAS) is a validated scale that measures scar quality by evaluating visual, tactile, and sensory characteristics of the scar from two different perspectives: the patient perspective and the surgeons' perspective.	Follow up at 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Split- thickness Skin grafting
• Other Study ID Numbers: Soh-Med-24-02-09MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final results
• IPD Sharing Time Frame: December 2023 to December 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No