Wound Healing, Dressing Type, and Dressing Change Frequency in THA (CAP-HIP)
Impact of Dressing Type and Dressing Change Frequency on Surgical Wound Healing Following Primary Total Hip Arthroplasty
Surgical wound complications following primary total hip arthroplasty remain a significant clinical challenge despite advances in wound care technologies. The optimal choice of dressing and frequency of dressing changes remain insufficiently investigated, particularly regarding their influence on wound healing and the wound microenvironment.
This prospective, randomized, controlled clinical trial aims to evaluate the impact of dressing type and dressing change frequency on surgical wound healing in patients undergoing primary total hip arthroplasty. Ninety patients will be allocated into three treatment groups receiving either a capillary-action dressing system (VACUTEX™) or standard dressings with different dressing change intervals.
The study will assess time to complete wound epithelialization, postoperative wound complications, pain intensity, wound temperature, exudate pH, length of hospital stay, and time to suture removal. In addition, the study will investigate the potential role of wound temperature and exudate pH as early indicators of impaired healing and postoperative complications.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study will be designed as a prospective, randomized, controlled clinical trial conducted at the Clinic for Orthopedic Surgery and Traumatology, University Clinical Centre of Vojvodina. A total of 90 patients undergoing primary total hip arthroplasty will be enrolled and randomly allocated into three parallel treatment groups using block randomization.
The participants will receive one of the following wound care protocols:
Group 1: VACUTEX™ capillary-action dressing, changed every 4 days until suture removal.
Group 2: Standard dressing with Octenisept® aqueous solution, changed every 3 days until suture removal.
Group 3: Standard dressing with Octenisept® aqueous solution, changed every 2 days until suture removal.
Baseline demographic and clinical data, including age, sex, body mass index (BMI), comorbidities, smoking status, previous orthopedic procedures, and preoperative laboratory parameters (blood glucose, HbA1c, and C-reactive protein), will be collected at admission.
The primary outcome will be time to complete wound epithelialization, defined as the number of days from surgery to complete wound closure without exudate, dehiscence, signs of infection, or need for additional wound interventions.
Secondary outcomes will include:
Incidence of local postoperative wound complications (surgical site infection, dehiscence, seroma, and hematoma according to CDC criteria); Postoperative pain intensity assessed using the Visual Analogue Scale (VAS); Local wound temperature; Wound exudate pH; Length of hospital stay; Time to suture removal. Initial wound assessment will be performed immediately after wound closure in the operating room (postoperative day 0). Subsequent assessments will be conducted at each scheduled dressing change according to the assigned treatment protocol. Wound temperature will be measured using a non-contact infrared thermometer, while exudate pH will be determined using a calibrated digital pH meter. Pain intensity will be evaluated at each assessment using the VAS.
Participants will be followed throughout hospitalization and during outpatient visits up to 30 days after surgery. In cases of wound-related complications, follow-up will be extended up to 90 postoperative days.
Data will be recorded in standardized case report forms and entered into a dedicated database for statistical analysis. Statistical analyses will be performed using IBM SPSS Statistics software. Appropriate parametric and non-parametric tests, repeated-measures analyses, survival analysis (Kaplan-Meier and Cox regression), and multivariable regression models will be used according to the type and distribution of the collected data. A p-value <0.05 will be considered statistically significant.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Andrijana Ćorić, MScN
- Número de telefone: +381611810756
- E-mail: 912007d23@mf.uns.ac.rs
Estude backup de contato
- Nome: Nemanja Gvozdenović, PhD, Associate Professor
- Número de telefone: +381646355614
- E-mail: nemanja.gvozdenovic@mf.uns.ac.rs
Locais de estudo
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Novi Sad, Sérvia, 21000
- Recrutamento
- Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
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Contato:
- Nemanja Gvozdenović, PhD, Associate Professor
- Número de telefone: +381646355614
- E-mail: nemanja.gvozdenovic@mf.uns.ac.rs
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients scheduled for primary total hip arthroplasty (THA)
- Age ≥ 65 years
- Ability to provide informed consent
- Patients with closed surgical incision suitable for standard postoperative wound care
Exclusion Criteria:
- Revision hip arthroplasty
- Active infection at the time of surgery
- Immunosuppressive therapy or severe immunodeficiency
- Known allergy to dressing materials used in the study
- Severe peripheral vascular disease affecting wound healing
- Inability to comply with follow-up protocol
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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Experimental: VACUTEX™ group
Patients receive wound care using the VACUTEX™ capillary action dressing system with dressing changes performed every 4 days until wound closure (suture removal).
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A capillary action-based wound management system designed for continuous removal of exudate without the use of external negative pressure, maintaining a moist wound environment and minimizing dressing adherence to the wound surface.
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Comparador Ativo: Standard dressing - 3-day change
Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 3 days until wound closure (suture removal).
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Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
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Comparador Ativo: Standard dressing - 2-day change
Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 2 days until wound closure (suture removal).
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Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
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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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Time to complete wound epithelialization
Prazo: Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)
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Time (in days) from surgery to complete wound epithelialization, defined as complete clinical closure of the surgical incision without exudate, dehiscence, or visible wound gaps, as assessed by clinical examination.
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Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrijana Ćorić, Faculty of Mediicne, University of Novi Sad
- Diretor de estudo: Nemanja Gvozdenović, Faculty of Mediicne, University of Novi Sad; Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
Publicações e links úteis
Publicações Gerais
- Tatarusanu SM, Lupascu FG, Profire BS, Szilagyi A, Gardikiotis I, Iacob AT, Caluian I, Herciu L, Gisca TC, Baican MC, Crivoi F, Profire L. Modern Approaches in Wounds Management. Polymers (Basel). 2023 Sep 4;15(17):3648. doi: 10.3390/polym15173648.
- Liu H, Zhang G, Wei A, Xing H, Han C, Chang Z. Effect of negative pressure wound therapy on the incidence of deep surgical site infections after orthopedic surgery: a meta-analysis and systematic review. J Orthop Surg Res. 2024 Sep 9;19(1):555. doi: 10.1186/s13018-024-05038-7.
- Garofalo S, Morano C, Bruno L, Pagnotta L. A Comprehensive Literature Review for Total Hip Arthroplasty (THA): Part 2-Material Selection Criteria and Methods. J Funct Biomater. 2025 May 18;16(5):184. doi: 10.3390/jfb16050184.
- Landen NX, Li D, Stahle M. Transition from inflammation to proliferation: a critical step during wound healing. Cell Mol Life Sci. 2016 Oct;73(20):3861-85. doi: 10.1007/s00018-016-2268-0. Epub 2016 May 14.
- Masson-Meyers DS, Andrade TAM, Caetano GF, Guimaraes FR, Leite MN, Leite SN, Frade MAC. Experimental models and methods for cutaneous wound healing assessment. Int J Exp Pathol. 2020 Feb;101(1-2):21-37. doi: 10.1111/iep.12346. Epub 2020 Mar 30.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Palavras-chave
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Outros números de identificação do estudo
- 00-37/20
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