Impact of Dressing Type and Dressing Change Frequency on Surgical Wound Healing Following Primary Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Octenisept® wound care dressing (Procedure)
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).
干预措施: VACUTEX™ wound dressing (Device)
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).
干预措施: Octenisept® wound care dressing (Procedure)
研究者
Nemanja Gvozdenović
Associate Proofessor Nemanja Gvozdenović
Clinical Center of Vojvodina