Influence of Antiseptic Washes on Wound Healing Complications After THA

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
F. Johannes Plate
Study ID
NCT07104084
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 9, 2025
Status verified
Feb 2026
Primary completion
Sep 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UPMC EastMonroevillePennsylvania15146
Dana Farrell, BS,PMP
(412) 383-0955
UPMC ShadysidePittsburghPennsylvania15232
Dana Farrell, BS,PMP
(412) 383-0955

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