Antiseptic Washes for Wound Healing After Hip Replacement

Recruiting at 1 trial location

Overseen By Dana Farrell, BS,PMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: F. Johannes Plate

Disqualifiers: Allergy to chlorhexidine, povidone-iodine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two washing solutions to determine which aids wound healing better after hip replacement surgery. Participants will have their surgical wounds washed with either a povidone-iodine solution or a chlorhexidine solution. This research is crucial because the best solution for preventing post-surgery complications remains unclear. Individuals with osteoarthritis or similar conditions who require hip replacement surgery might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have safely used chlorhexidine in surgeries, such as total joint replacements. It cleans the skin and surgical areas, reducing infection risk. Research has shown it can lower infection rates and is well-tolerated by patients.

For povidone-iodine, studies suggest it is effective and safe during surgeries. It reduces infections when used to clean surgical wounds. This solution is cost-effective and has been widely used without major safety concerns.

Both solutions have proven safe for use in surgical settings, making them reliable options for cleaning wounds after hip replacements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these antiseptic washes because they offer potentially improved methods for wound healing after hip replacement surgery. Chlorhexidine and povidone-iodine are both known for their strong antibacterial properties, which could reduce infection rates more effectively than standard saline solutions or topical antibiotics. Unlike typical wound care methods that rely on passive antiseptic application, these washes involve a direct lavage technique, allowing for more thorough cleaning of the surgical area. This approach may lead to faster recovery times and fewer complications, making these solutions promising alternatives in post-surgical care.

What evidence suggests that these washing solutions could be effective for wound healing after hip replacement?

This trial will compare the effectiveness of chlorhexidine and povidone-iodine washing solutions in wound healing after hip replacement. Research has shown that chlorhexidine effectively reduces infections at the site of hip and knee surgeries. This antiseptic is often used before surgery to lower the risk of infection. Similarly, studies on povidone-iodine indicate it is also effective in preventing infections after surgeries like hip replacements. Some research suggests that both solutions work well, but neither clearly outperforms the other in reducing infection rates. Both chlorhexidine and povidone-iodine are trusted for cleaning the skin and preventing complications after surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Frank J Plate, MD, PhD

Principal Investigator

University of Pittsburgh

Frank J Plate, MD, PhD

Principal Investigator

University of Pittsburgh

Frank J Plate, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals undergoing total hip replacement surgery due to conditions like Perthes Disease, Hip Osteoarthritis, or Avascular Necrosis. Participants must be suitable for the standard procedure without any special modifications.

Inclusion Criteria

I need a hip replacement due to severe arthritis or bone death.

Exclusion Criteria

Reported or documented allergy to chlorhexidine or povidone-iodine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total hip replacement surgery with either povidone-iodine or chlorhexidine washing solution

1 day

1 visit (in-person)

Follow-up

Participants are monitored for wound healing and complications at 2-week and 6-week postoperative visits

6 weeks

2 visits (in-person)

Extended Follow-up

Participants are monitored for wound healing complications and potential revision surgeries up to 90 days post-surgery

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine
• Povidone-Iodine

Trial Overview The study compares two antiseptic washes used during hip replacement surgery: povidone-iodine and chlorhexidine. Patients will be randomly assigned to one of these treatments to see which is better for wound healing post-surgery.

How Is the Trial Designed?

Group I: Povidone-iodine washing solution Experimental Treatment 1 Intervention

Following component implantation a 3-minute povidone-iodine lavage followed by saline lavage will be performed.

Group II: Chlorhexidine washing solution Experimental Treatment 1 Intervention

Following component implantation a 3-minute chlorhexidine lavage followed by saline lavage will be performed.

Who Is Running the Clinical Trial?

F. Johannes Plate

Lead Sponsor

Trials

1

Recruited

100+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671291/

Efficacy of surgical skin preparation solutions in hip ... DuraPrep was more effective than ChloraPrep at eliminating skin flora at the hip initially on application, but the 2 solutions were equally ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919117301267

Review Preoperative chlorhexidine reduces the incidence ... The present meta-analysis indicated that preadmission chlorhexidine protocol was an effective way to reduce surgical site infection in total knee and hip ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03393819

Efficacy of Surgical Skin Preparation Solutions in Hip ... This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep ( ...

4. mdpi.com mdpi.com/2077-0383/10/3/434

The Prevention of Periprosthetic Joint Infection in Primary ... The aim of this study was to investigate whether preoperative bathing using chlorhexidine gluconate (CHG) before THA can effectively reduce the postoperative ...

5. hipandpelvis.or.kr hipandpelvis.or.kr/journal/view.html?volume=36&number=3&spage=161

Evidence-based Approach for Prevention of Surgical Site ... The longer-term survival rates for PJI after total hip and knee arthroplasty correspond with or are lower than those for prevalent cancers in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5423571/

Use of Chlorhexidine Preparations in Total Joint Arthroplasty Chlorhexidine can be used for pre-operative skin cleansing, surgical site preparation, hand antisepsis of the surgical team and intra-articular irrigation of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352344122002308

Prosthetic Joint Infection and Wound Leakage After the ... Intraoperative chlorhexidine irrigation could be a valuable additive to systemic antibiotics to prevent infections after total joint arthroplasties.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5712016/

Intraoperative chlorhexidine irrigation to prevent infection ... The purpose of this study was to evaluate the effect of chlorhexidine gluconate (CHG) irrigation on infection rates following THA and TKA.

9. jeo-esska.springeropen.com jeo-esska.springeropen.com/articles/10.1186/s40634-022-00503-w

Chlorhexidine gluconate lavage during total joint arthroplasty ... This study suggests CHG may be as efficacious as dilute betadine in preventing PJI while also decreasing the risk of superficial drainage and wound ...