Effectiveness of Negative Pressure Wound Therapy Dressing on Split-Thickness Skin Graft Donor Site Wound Healing
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Qina, Egypte
- South Valley University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
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.
|
|
Comparateur factice: 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. |
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The complete re-epithelialization time
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
pain intensity
Délai: 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
Délai: 14 days
|
The frequency of dressing changes required until complete donor site wound healing was recorded.
|
14 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Histology
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- bode:SVU-MED-PIS013-4-24-7-883
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .