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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing; Split-thickness Skin Graft Donor Sites
• Intervention / Treatment: Procedure: Negative Pressure Wound therapy; Procedure: conventional dressing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qina, Egypt
    • South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The inclusion criteria were patients who required a split-thickness skin graft procedure due to any etiology, had donor site wounds not exceeding 5% of the total body surface area, and complied with the necessary wound care and follow-up protocols.

Exclusion Criteria:

• The exclusion criteria included patients who had physical or cognitive impairment and were unable to provide informed consent or comply with necessary wound protocol, as well as patients on anticoagulant, corticosteroid, or chemotherapy treatment. Additionally, patients with donor site wounds exceeding 5% of their total body surface area were excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NPWT Group; 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; 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.
Sham Comparator: Conventional Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	Pain was objectively assessed using a visual analog scale, which scored the pain from 0 (no pain) to 10 (worst pain). The pain intensities of both sides of the donor site wound were recorded, and each patient reported their feelings of pain at the donor site wound on postoperative days 1, 2, 3, and 7.	7 days
Dressing changes	The frequency of dressing changes required until complete donor site wound healing was recorded.	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histology	3-mm punch biopsies were taken from the NPWT and the control donor areas on the 14th postoperative day to compare the histological response to wounding. Each specimen was fixed in 10% formalin solution for 24 hours, then processed for paraffin embedding. Paraffin sections (4 µm thickness) were cut and stained with hematoxylin and Eosin stain (H&E). Four photomicrographs (at a magnification of x100) from non-overlapping fields were taken from each H&E -stained slides from each skin biopsy specimen and were examined by the image-J software. Thickness of the epidermis in micrometers (µm) was measured at different three sites in each photomicrograph from H&E -stained slides, from the top of the stratum granulosum to the basement membrane of stratum basale at the dermo-epidermal junction (DEJ) at the top of dermal papillae with exclusion of sites of the epidermal papillae. An immunohistochemical (IHC) staining of formalin-fixed paraffin-embedded skin sections using anti-CD45 marker (rat m	14 day

Collaborators and Investigators

• Sponsor: Mahmoud Abdalla Hifny Taha

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Drainage; Wound Closure Techniques; Negative-Pressure Wound Therapy
• Other Study ID Numbers: bode:SVU-MED-PIS013-4-24-7-883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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