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| Name | Class |
|---|---|
| Irrimax Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine washing solution | Experimental | Following component implantation a 3-minute chlorhexidine lavage followed by saline lavage will be performed. |
|
| Povidone-iodine washing solution | Experimental | Following component implantation a 3-minute povidone-iodine lavage followed by saline lavage will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lavage chlorhexidine | Device | Patient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks and 6 weeks postop |
| Measure | Description | Time Frame |
|---|---|---|
| wound healing complications | drainage, dehiscence, suture abscess | up to 90 days from surgery |
| Revision | Revision surgery, readmission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank J Plate, MD, PhD | Contact | (412) 687-3900 | platefj2@upmc.edu | |
| Dana Farrell, BS,PMP | Contact | (412) 383-0955 | djf52@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank J Plate, MD, PhD | University of Pittsburgh | Principal Investigator |
| Frank J Plate, MD, PhD | University of Pittsburgh | Study Director |
| Frank J Plate, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC East | Recruiting | Monroeville | Pennsylvania | 15146 | United States |
Anonymous outcomes comparing wound healing complication rates, revision and readmission rates with mean anonymous demographic data will be published.
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| lavage povidone-iodine | Device | Patient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage. |
|
| up to 90 days from surgery |
| University of Pittsburgh |
| Study Chair |
| UPMC Shadyside | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
|
| D012216 |
| Rheumatic Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |