Antibacterial Incise Drape for Knee and Hip Replacement Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the use of a special drape containing the antimicrobial agent chlorhexidine gluconate (CHG) during hip or knee replacement surgeries. The researchers aim to assess how effectively this drape prevents bacterial contamination at the surgical site and its safety during the operation. It suits individuals needing a primary (first-time) hip or knee replacement, who haven't recently taken antibiotics, and have no history of joint infections. During surgery, participants will have the CHG drape applied, and samples will be collected to check for bacteria. As an unphased trial, this study offers a unique opportunity to contribute to advancements in surgical safety.
What prior data suggests that this incise drape is safe for knee and hip replacement surgery?
Research shows that the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape can reduce the risk of infection during surgery, lowering the chance of infection at the surgical site. In past studies, patients using similar drapes experienced fewer infections, suggesting that the drape is safe and comfortable. The chlorhexidine gluconate (CHG) in the drape kills bacteria, helping to maintain a clean surgical area. Overall, the drape has demonstrated effectiveness, with no major safety issues reported.12345
Why are researchers excited about this trial?
Unlike the standard care options for preventing infections during hip and knee replacements, such as topical antiseptics and systemic antibiotics, the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape offers a unique approach by combining an antimicrobial barrier with a surgical drape. This incise drape is impregnated with chlorhexidine gluconate (CHG), which continuously releases antiseptic at the surgical site throughout the procedure. Researchers are excited about this treatment because it provides an added layer of protection against infection directly at the incision site, potentially reducing the risk of post-surgical infections more effectively than traditional methods.
What evidence suggests that this antimicrobial incise drape is effective for preventing bacterial contamination during hip and knee replacement surgery?
Research has shown that the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape can help reduce bacteria during surgery. In studies, surgical cuts covered with these special drapes had fewer bacteria compared to those without. Specifically, 12% of cuts with the drape had bacteria, while 27% of those without did. This suggests that using the drape during knee or hip replacement surgeries might lower the risk of infection. The drape also adheres well and remains in place during surgery, helping to keep the area clean. Participants in this trial will receive this drape as part of their surgical procedure.25678
Are You a Good Fit for This Trial?
This trial is for adults over the age of 22 who are scheduled for primary hip or knee replacement surgery and can give informed consent. Participants must be able to return for all required visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo primary hip or knee arthroplasty with a CHG-impregnated antimicrobial incise drape applied during surgery
Follow-up
Participants are monitored for safety and effectiveness after surgery
What Are the Treatments Tested in This Trial?
Interventions
- 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape
Trial Overview
The study tests a CHG-impregnated antimicrobial incise drape (3M™ Ioban™) during hip or knee arthroplasty procedures, assessing its effectiveness in preventing bacterial contamination at the surgical site.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Subjects undergoing primary hip or knee arthroplasty will have a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape applied to the surgical site prior to incision and maintained in place for the duration of the surgical procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Solventum US LLC
Lead Sponsor
Bryan Hanson
Solventum US LLC
Chief Executive Officer since 2024
Bachelor's degree in Business Administration from Indiana University
Dr. Ryan Egeland
Solventum US LLC
Chief Medical Officer
MD, trained in Plastic and Reconstructive Surgery
Citations
Evaluation of Incise Drape Lift Using 2% Chlorhexidine ...
This is a randomized controlled study using a human volunteer knee model (n = 30) to evaluate the adhesion performance of an incise drape comparing 2 skin ...
Study Details | NCT07356323 | A Prospective, Single-arm ...
The study evaluates the intraoperative performance and safety of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape used ...
Evaluation of Incise Drape Lift Using 2% Chlorhexidine ...
The frequency of drape lift was recorded after each challenge. Results: After dry flex, 4 of 60 samples (6.7%) had lifted on prep A and 0 on ...
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.
3M™ Ioban™ 2 Antimicrobial Incise Drape, 6600 Series
12% of incisions with iodophor-impregnated adhesive drape and 27% without adhesive drapes were positive for bacterial colonization at closure of surgery (OR= ...
6.
solventum.com
solventum.com/content/dam/public/language-masters/en/msb/document/2025/ioban-chg-drape-brochure-ms-ss-en.pdfIoban CHG Chlorhexidine Gluconate Incise Drape Brochure
The 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape* is a cost- effective solution to help reduce the risk of surgical site infections, making it a prudent ...
May 18, 2023 3M Company Hilary Hovde Regulatory Affairs ...
The. Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination ...
8.
multimedia.3m.com
multimedia.3m.com/mws/media/1391880O/3m-ioban-2-antimicrobial-incise-drapes-clinical-evidence-summary.pdf3M™ Ioban™ 2 Antimicrobial Incise Drapes
Findings. • Ioban 2 Antimicrobial Incise Drape was associated with a significant reduction in the incidence of overall SSIs. (P = .001).
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