Influence of Antiseptic Washes on Wound Healing Complications After THA

F. Johannes Plate

Status: Enrolling

Conditions: Hip Osteoarthritis; Avascular Necrosis of Femur Head

Treatments: Device: lavage chlorhexidine; Device: lavage povidone-iodine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07104084

STUDY25020138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Chlorhexidine washing solution

Experimental group

Description:

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

Treatment:

Device: lavage chlorhexidine

Povidone-iodine washing solution

Experimental group

Description:

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

Treatment:

Device: lavage povidone-iodine