Recruiting

Povidone-Iodine vs. Chlorhexidine

Sponsor:

F. Johannes Plate

Code:

NCT07104084

Conditions

Hip Osteoarthritis

Avascular Necrosis of Femur Head

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

lavage chlorhexidine

lavage povidone-iodine

Study Details

Brief 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.

Conditions

Hip Osteoarthritis

Avascular Necrosis of Femur Head

Study ID

NCT07104084

Start date

Oct 9, 2025

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • reported or documented allergy to chlorhexidine or povidone-iodine

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Chlorhexidine washing solution

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

experimental: Povidone-iodine washing solution

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

Interventions

lavage chlorhexidine

Patient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage.

lavage povidone-iodine

Patient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage.

Primary outcome measure

  • Patient and Observer Scar Assessment Scale [ Time Frame: 2 weeks and 6 weeks postop ]

Central Contacts and Locations

Central contacts

Frank J Plate, MD, PhD

(412) 687-3900platefj2@upmc.edu

Dana Farrell, BS,PMP

(412) 383-0955djf52@pitt.edu

Locations

UPMC East

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Dana Farrell, BS,PMP

(412) 383-0955djf52@pitt.edu

UPMC Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Dana Farrell, BS,PMP

(412) 383-0955djf52@pitt.edu

More Information

Sponsor

F. Johannes Plate

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by F. Johannes Plate on 2026-02-05.