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

1. Juni 2026 aktualisiert von: Mahmoud Abdalla Hifny Taha
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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

12

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Ägypten
      • Qina, Ägypten
        • South Valley University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verfahren: 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.
Schein-Komparator: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The complete re-epithelialization time
Zeitfenster: 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.
14 days
Assessment of the re-epithelialization
Zeitfenster: 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.
14 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
pain intensity
Zeitfenster: 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.
7 days
Dressing changes
Zeitfenster: 14 days
The frequency of dressing changes required until complete donor site wound healing was recorded.
14 days

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Histology
Zeitfenster: 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
14 day

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mahmoud Abdalla Hifny Taha

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2023

Primärer Abschluss (Tatsächlich)

30. August 2024

Studienabschluss (Tatsächlich)

30. August 2024

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • bode:SVU-MED-PIS013-4-24-7-883

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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