NCT07104084

Influence of Antiseptic Washes on Wound Healing Complications After THA

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: F. Johannes Plate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hip Osteoarthritis
• Avascular Necrosis of Femur Head

Interventions

Type	Name	Description
DEVICE	lavage chlorhexidine	Patient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage.
DEVICE	lavage povidone-iodine	Patient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage.

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-09-01
• Completion: 2028-01-01
• First posted: 2025-08-05
• Last updated: 2026-02-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study