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Wound Healing, Dressing Type, and Dressing Change Frequency in THA (CAP-HIP)

2026年7月8日 更新者:Nemanja Gvozdenović、Clinical Center of Vojvodina

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Novi Sad、塞尔维亚、21000
        • 招聘中
        • Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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).
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.
有源比较器: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).
Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
有源比较器: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).
Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time to complete wound epithelialization
大体时间:Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)
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.
Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andrijana Ćorić、Faculty of Mediicne, University of Novi Sad
  • 研究主任:Nemanja Gvozdenović、Faculty of Mediicne, University of Novi Sad; Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

IPD will not be shared publicly. Only aggregated and anonymized study results will be published in scientific journals and presented at conferences.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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