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NCT Number: NCT07629076

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.

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Key information

Conditions

Split-thickness Skin Graft Donor Sites Wound Healing

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University

Qina, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The complete re-epithelialization time

    Time frame: 14 days

    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.

  2. Assessment of the re-epithelialization

    Time frame: 14 days

    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.

Secondary outcomes

  1. pain intensity

    Time frame: 7 days

    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.

  2. Dressing changes

    Time frame: 14 days

    The frequency of dressing changes required until complete donor site wound healing was recorded.

Other outcomes

  1. Histology

    Time frame: 14 day

    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

Sponsors and collaborators

Lead sponsor

Mahmoud Abdalla Hifny Taha

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

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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