Avascular Necrosis of Femur Head, Hip Osteoarthritis
Conditions
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.
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.
Interventions
DEVICElavage chlorhexidine
Patient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage.
DEVICElavage povidone-iodine
Patient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage.
Sponsors
F. Johannes Plate
Irrimax Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale | 2 weeks and 6 weeks postop | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound healing complications | up to 90 days from surgery | drainage, dehiscence, suture abscess |
| Revision | up to 90 days from surgery | Revision surgery, readmission |
Countries
United States
Contacts
CONTACTFrank J Plate, MD, PhD
CONTACTDana Farrell, BS,PMP
PRINCIPAL_INVESTIGATORFrank J Plate, MD, PhD
University of Pittsburgh
STUDY_DIRECTORFrank J Plate, MD, PhD
University of Pittsburgh
STUDY_CHAIRFrank J Plate, MD, PhD
University of Pittsburgh
Outcome results
None listed