Effectiveness of Negative Pressure Wound Therapy Dressing on Split-Thickness Skin Graft Donor Site Wound Healing

NCT07629076 | Completed

• 1 other identifier: bode:SVU-MED-PIS013-4-24-7-883
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Split-thickness skin grafting (STSG) is a cornerstone of reconstructive surgery, but donor sites often experience significant morbidity due to partial-thickness wounds created. Accelerating the re-epithelialization of these donor sites is crucial for minimizing complications. Negative pressure wound therapy (NPWT) has shown potential in enhancing the re-epithelialization of donor site wounds. However, further research is needed to compare NPWT's efficacy against conventional normal pressure dressings comprehensively. This study aims to compare the effectiveness of NPWT with conventional dressings in promoting skin graft donor sites healing.

Conditions

Wound Healing; Split-thickness Skin Graft Donor Sites

Outcome Measures

Primary Outcomes (2)

• The complete re-epithelialization time

  The time to complete re-epithelialization, or healing time, was defined as the number of days required to achieve full epithelialization of the donor site, with no further need for wound dressing. Epithelialization was considered complete when the entire wound area of the STSG donor site was covered with epithelium.

  14 days

• Assessment of the re-epithelialization

  The re-epithelialization was assessed on the 14th day after completely removing the dressing from both donor sites. Photographs of the donor sites were taken, and the percentage of epithelialization was quantified by analyzing the images using histogram-based image processing software (Adobe Photoshop R). The histogram depicts the distribution of pixels in an image by graphing the number of pixels at each color intensity level. The non-epithelialized area was initially identified and selected using the color range tool. The Fuzziness toolbar was then adjusted to select any missing tissues, including the entire non-epithelialized area. The number of pixels within the selection was determined, and the percentage of epithelialization was calculated by dividing the number of pixels in the non-epithelialized area by the total number of pixels within the total donor site wound surface area.

  14 days

Secondary Outcomes (2)

• pain intensity

  7 days

• Dressing changes

  14 days

Other Outcomes (1)

• Histology

  14 day

Study Arms (2)

NPWT Group

ACTIVE COMPARATOR

All patients enrolled in this study were their own controls with two STSG donor sites per patient. Each patient had two skin graft donor sites, one on each thigh, with one site treated with negative-pressure wound therapy dressings and the other treated with conventional dressings using petroleum gauze without application of negative pressure. The assignment of dressing methods was randomized using a simple randomization technique. Split-thickness donor site wound management All skin grafts were consistently harvested from the proximal anterolateral thigh region, using an electrically powered dermatome (Zimmer, Zimmer Surgical Inc.). The thickness of the skin grafts was uniformly set at 0.3 mm to minimize variability across cases.

Procedure: Negative Pressure Wound therapy

Conventional Group

SHAM COMPARATOR

All patients enrolled in this study were their own controls with two STSG donor sites per patient. Each patient had two skin graft donor sites, one on each thigh, with one site treated with negative-pressure wound therapy dressings and the other treated with conventional dressings using petroleum gauze without application of negative pressure. The assignment of dressing methods was randomized using a simple randomization technique. Split-thickness donor site wound management All skin grafts were consistently harvested from the proximal anterolateral thigh region, using an electrically powered dermatome (Zimmer, Zimmer Surgical Inc.). The thickness of the skin grafts was uniformly set at 0.3 mm to minimize variability across cases.

Procedure: conventional dressing

Interventions

Negative Pressure Wound therapy PROCEDURE

In the NPWT method, we first applied non-adherent petroleum gauze to the donor site wound. The NPWT system (Model: NP-800, Medway Inc., Suwanee GA, USA) was then fixed, and the pressure was continuously set to 100 mm Hg for seven days. On the 7th postoperative day, the NPWT system was removed and replaced with a conventional dressing while keeping the inner petroleum gauze dressing in situ.

NPWT Group

conventional dressing PROCEDURE

In the conventional dressing method, the donor wound was first covered by non-adherent petroleum gauze (Sufre-tulle) and then managed in a closed fashion, with gauze and cotton as a secondary normal pressure dressing. The secondary dressing was changed depending upon the associate's dressing soaking, hematoma, or suspicion of wound infection without disruption of underlying petroleum gauze.

Conventional Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mahmoud Abdalla Hifny Taha: lead

Study Sites (1)

South Valley University

Qina, Egypt

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: January 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)