Influence of Antiseptic Washes on Wound Healing Complications After THA

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

Interventions

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.

Sponsors & Collaborators

• Irrimax Corporation

  collaborator INDUSTRY

• F. Johannes Plate

  lead OTHER

Principal Investigators

• Frank J Plate, MD, PhD · University of Pittsburgh

• Frank J Plate, MD, PhD · University of Pittsburgh

• Frank J Plate, MD, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-09

Primary Completion

2027-09-01

Completion

2028-01-01

FDA Device

Yes

Countries

• United States

Study Locations