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临床试验/NCT07104084
NCT07104084招募中不适用

Comparison of Wound Healing Complications After Anterior Total Hip Arthroplasty Using Povidone-iodine or Chlorhexidine as Antiseptic Wash

F. Johannes Plate2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2025年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
420
试验地点
2
主要终点
Patient and Observer Scar Assessment Scale

研究概览

简要总结

The purpose of this research trial is to evaluate the effect of two types of washing solutions on wound healing after total hip replacement surgery. Washing solutions are used routinely during total hip replacements to clean the wound after the components have been placed and the wound is about to be closed with sutures. It is currently not known which washing solution may be better for wound healing and whether a certain solution decreases the risk of wound healing complications after total hip replacement. Therefore, this research trial is being conducted.

Study participants will be randomized into one of two groups: washing the surgical wound with povidone-iodine solution (Surgiphor, Becton Dickinson, Franklin Lakes, NJ) or chlorhexidine solution (Irrisept, Irrimax Corporation, Lawrenceville, GA). All patients will undergo standard of care total hip replacements without any other change in surgery. The best type of solution that cleans the wound and potentially leads to better wound healing is unknown. This study will evaluate whether there is difference in surgical wound healing between the two washing solutions. The study will pay for the washing solutions. Patients will follow up for standard postoperative visits. At the 2-week and 6-week visits, pictures of the surgical incision will be taken and saved in the electronic medical record and evaluated in a standardized way for healing of the incision and the appearance of the scar. Postoperative complications and returns to the hospital or additional surgeries will be collected from the electronic medical record.

详细描述

Study participants will be randomized into one of two groups: washing the surgical wound with povidone-iodine solution (Surgiphor, Becton Dickinson, Franklin Lakes, NJ) or chlorhexidine solution (Irrisept, Irrimax Corporation, Lawrenceville, GA). All patients will undergo standard of care total hip replacements without any other change in surgery. The best type of solution that cleans the wound and potentially leads to better wound healing is unknown. This study will evaluate whether there is difference in surgical wound healing between the two washing solutions. Patients will follow up for standard postoperative visits. At the 2-week and 6-week visits, pictures of the surgical incision will be taken and saved in the electronic medical record and evaluated in a standardized way for healing of the incision and the appearance of the scar. Postoperative complications and returns to the hospital or additional surgeries will be collected from the electronic medical record.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • osteoarthritis or avascular necrosis of the femoral head, failed conservative management, indicated for total hip replacement

排除标准

  • reported or documented allergy to chlorhexidine or povidone-iodine

研究组 & 干预措施

Chlorhexidine washing solution

Experimental

Following component implantation a 3-minute chlorhexidine lavage followed by saline lavage will be performed.

干预措施: lavage chlorhexidine (Device)

Povidone-iodine washing solution

Experimental

Following component implantation a 3-minute povidone-iodine lavage followed by saline lavage will be performed.

干预措施: lavage povidone-iodine (Device)

结局指标

主要结局

Patient and Observer Scar Assessment Scale

时间窗: 2 weeks and 6 weeks postop

The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location

次要结局

  • wound healing complications(up to 90 days from surgery)
  • Revision(up to 90 days from surgery)

研究者

发起方
F. Johannes Plate
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

F. Johannes Plate

Associate Professor

University of Pittsburgh

研究点 (2)

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