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NCT07104084 | RECRUITING | Hip Osteoarthritis


Influence of Antiseptic Washes on Wound Healing Complications After THA
Sponsor:

F. Johannes Plate

Information provided by (Responsible Party):

F. Johannes Plate

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.

Condition or disease

Hip Osteoarthritis

Avascular Necrosis of Femur Head

Intervention/treatment

lavage chlorhexidine

lavage povidone-iodine

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 420 participants
Masking : SINGLE
Primary Purpose : PREVENTION
Official Title : Comparison of Wound Healing Complications After Anterior Total Hip Arthroplasty Using Povidone-iodine or Chlorhexidine as Antiseptic Wash
Actual Study Start Date : 2025-10-09
Estimated Primary Completion Date : 2027-09-01
Estimated Study Completion Date : 2028-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Influence of Antiseptic Washes on Wound Healing Complications After THA

Location Details

NCT07104084


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Locations


RECRUITING

United States, Pennsylvania

UPMC East

Monroeville, Pennsylvania, United States, 15146

RECRUITING

United States, Pennsylvania

UPMC Shadyside

Pittsburgh, Pennsylvania, United States, 15232

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