Influence of Antiseptic Washes on Wound Healing Complications After THA
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Monroeville 5201734, Pennsylvania 6254927 15146
Pittsburgh 5206379, Pennsylvania 6254927 15232
More Details
- NCT ID
- NCT07104084
- Status
- Recruiting
- Sponsor
- F. Johannes Plate
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.