Effectiveness of Negative Pressure Wound Therapy Dressing on Split-Thickness Skin Graft Donor Site Wound Healing
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Qina, Egito
- South Valley University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
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Comparador Falso: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The complete re-epithelialization time
Prazo: 14 days
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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.
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14 days
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Assessment of the re-epithelialization
Prazo: 14 days
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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.
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14 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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pain intensity
Prazo: 7 days
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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.
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7 days
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Dressing changes
Prazo: 14 days
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The frequency of dressing changes required until complete donor site wound healing was recorded.
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14 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Histology
Prazo: 14 day
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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
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- bode:SVU-MED-PIS013-4-24-7-883
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