Influence of Antiseptic Washes on Wound Healing Complications After THA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorF. Johannes Plate

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

osteoarthritis or avascular necrosis of the femoral head, failed conservative management, indicated for total hip replacement

Disqualifiers

reported or documented allergy to chlorhexidine or povidone-iodine

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Chlorhexidine washing solutionExperimental treatment 1 intervention
Group B: Povidone-iodine washing solutionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient and Observer Scar Assessment Scale

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

Time frame
2 weeks and 6 weeks postop

Secondary outcomes

1

wound healing complications

drainage, dehiscence, suture abscess

Time frame
up to 90 days from surgery
2

Revision

Revision surgery, readmission

Time frame
up to 90 days from surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

F. Johannes Plate

Lead sponsor

University of Pittsburgh

Sponsor institution

Irrimax Corporation

Collaborator