Influence of Antiseptic Washes on Wound Healing Complications After THA

NCT ID: NCT07104084

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-08
• Study Completion Date: 2028-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Chlorhexidine washing solution

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

Group Type: EXPERIMENTAL

lavage chlorhexidine

Intervention Type: DEVICE

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

Povidone-iodine washing solution

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

Group Type: EXPERIMENTAL

lavage povidone-iodine

Intervention Type: DEVICE

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

Interventions

lavage chlorhexidine

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

Intervention Type: DEVICE

lavage povidone-iodine

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irrimax Corporation

INDUSTRY

Sponsor Role: collaborator

F. Johannes Plate

OTHER

Sponsor Role: lead

Responsible Party

F. Johannes Plate

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frank J Plate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Frank J Plate, MD, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Frank J Plate, MD, PhD

Role: STUDY_CHAIR

University of Pittsburgh

Locations

UPMC East

Monroeville, Pennsylvania, United States

Site Status: RECRUITING

UPMC Shadyside

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Frank J Plate, MD, PhD

Role: CONTACT

platefj2@upmc.edu

(412) 687-3900

Dana Farrell, BS,PMP

Role: CONTACT

djf52@pitt.edu

(412) 383-0955

Facility Contacts

Dana Farrell, BS,PMP

Role: primary

djf52@pitt.edu

(412) 383-0955

Dana Farrell, BS,PMP

Role: primary

djf52@pitt.edu

(412) 383-0955

Other Identifiers

STUDY25020138

Identifier Type: -

Identifier Source: org_study_id