Influence of Antiseptic Washes on Wound Healing Complications After THA

NCT07104084 | Recruiting FDA Device

• 1 other identifier: STUDY25020138
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Patient and Observer Scar Assessment Scale

  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

  2 weeks and 6 weeks postop

Secondary Outcomes (2)

• wound healing complications

  up to 90 days from surgery

• Revision

  up to 90 days from surgery

Study Arms (2)

Chlorhexidine washing solution

EXPERIMENTAL

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

Device: lavage chlorhexidine

Povidone-iodine washing solution

EXPERIMENTAL

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

Device: lavage povidone-iodine

Interventions

lavage chlorhexidine DEVICE

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

Chlorhexidine washing solution

lavage povidone-iodine DEVICE

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

Povidone-iodine washing solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• reported or documented allergy to chlorhexidine or povidone-iodine

Sponsors & Collaborators

• F. Johannes Plate: lead
• Irrimax Corporation: collaborator

Study Sites (2)

UPMC East

Monroeville, Pennsylvania, 15146, United States

RECRUITING

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank J Plate, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Frank J Plate, MD, PhD

  University of Pittsburgh

  STUDY DIRECTOR

• Frank J Plate, MD, PhD

  University of Pittsburgh

  STUDY CHAIR

Central Study Contacts

Frank J Plate, MD, PhD

CONTACT

(412) 687-3900; platefj2@upmc.edu

Dana Farrell, BS,PMP

CONTACT

(412) 383-0955; djf52@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 5, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)