Hip OsteoarthritisNCT07104084
Influence of Antiseptic Washes on Wound Healing Complications After THA
A study testing lavage chlorhexidine and lavage povidone-iodine in people with Hip Osteoarthritis and Avascular Necrosis of Femur Head, run by F. Johannes Plate at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Avascular Necrosis of Femur Head
- What is being tested?
- lavage chlorhexidine and lavage povidone-iodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis or avascular necrosis of the femoral head, failed conservative management, indicated for total hip replacement
Who cannot join
- reported or documented allergy to chlorhexidine or povidone-iodine
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UPMC East
Monroeville, Pennsylvania, 15146
Dana Farrell, BS,PMP, (412) 383-0955, djf52@pitt.edu
- Recruiting
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
Dana Farrell, BS,PMP, (412) 383-0955, djf52@pitt.edu
About this study
Official title: Comparison of Wound Healing Complications After Anterior Total Hip Arthroplasty Using Povidone-iodine or Chlorhexidine as Antiseptic Wash
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.
Read the 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.
- Being tested
- lavage chlorhexidine, lavage povidone-iodine
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lavage chlorhexidineDevice
Patient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage.
lavage povidone-iodineDevice
Patient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine washing solution | Experimental | Following component implantation a 3-minute chlorhexidine lavage followed by saline lavage will be performed. Receives: Device: lavage chlorhexidine |
| Povidone-iodine washing solution | Experimental | Following component implantation a 3-minute povidone-iodine lavage followed by saline lavage will be performed. Receives: Device: lavage povidone-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks and 6 weeks postop
Secondary outcomes (2)
wound healing complications
drainage, dehiscence, suture abscess
Measured: up to 90 days from surgery
Revision
Revision surgery, readmission
Measured: up to 90 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start9 Oct 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F. Johannes Plate
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor-investigator, F. Johannes Plate, University of Pittsburgh
- Investigators
- Frank J Plate, MD, PhD, Principal investigator, University of PittsburghFrank J Plate, MD, PhD, Study director, University of PittsburghFrank J Plate, MD, PhD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104084
- Sponsor's protocol ID
- STUDY25020138
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymous outcomes comparing wound healing complication rates, revision and readmission rates with mean anonymous demographic data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wound Healing Complications After Anterior Total Hip Arthroplasty Using Povidone-iodine or Chlorhexidine as Antiseptic Wash
- ClinicalTrials.gov ID
- NCT07104084
- Acronym / sponsor ID
- STUDY25020138
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- F. Johannes PlateUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine washing solution | Experimental | Device: lavage chlorhexidineFollowing component implantation a 3-minute chlorhexidine lavage followed by saline lavage will be performed. |
| Povidone-iodine washing solution | Experimental | Device: lavage povidone-iodineFollowing component implantation a 3-minute povidone-iodine lavage followed by saline lavage will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- osteoarthritis or avascular necrosis of the femoral head, failed conservative management, indicated for total hip replacement
Key exclusion criteria (1 listed)
- reported or documented allergy to chlorhexidine or povidone-iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lavage chlorhexidinePatient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage. | Device | Chlorhexidine washing solution |
| lavage povidone-iodinePatient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage. | Device | Povidone-iodine washing solution |
Primary outcome
Patient and Observer Scar Assessment Scale
Time frame: 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
2 secondary outcomes
wound healing complications
Time frame: up to 90 days from surgery
Revision
Time frame: up to 90 days from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymous outcomes comparing wound healing complication rates, revision and readmission rates with mean anonymous demographic data will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank J Plate, MD, PhD principal investigator
University of Pittsburgh
Frank J Plate, MD, PhD study director
University of Pittsburgh
Frank J Plate, MD, PhD study chair
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lavage chlorhexidine and lavage povidone-iodine in people with Hip Osteoarthritis and Avascular Necrosis of Femur Head, run by F. Johannes Plate at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank J Plate, MD, PhD ((412) 687-3900, platefj2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (time frame: 2 weeks and 6 weeks postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.