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NCT Number: NCT07104084

Influence of Antiseptic Washes on Wound Healing Complications After THA

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC East, Monroeville, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lavage chlorhexidine

Device

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

lavage povidone-iodine

Device

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

Primary outcomes

  1. Patient and Observer Scar Assessment Scale

    Time frame: 2 weeks and 6 weeks postop

    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

Secondary outcomes

  1. wound healing complications

    Time frame: up to 90 days from surgery

    drainage, dehiscence, suture abscess

  2. Revision

    Time frame: up to 90 days from surgery

    Revision surgery, readmission

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Farrell, BS,PMP

CONTACT

[email protected]

(412) 383-0955

Frank J Plate, MD, PhD

CONTACT

[email protected]

(412) 687-3900

Sponsors and collaborators

Lead sponsor

F. Johannes Plate

Other

Collaborators

  • Irrimax Corporation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 5, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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