Arthroplasty Replacement, KneeNCT07356323
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
A study testing 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG) in people with Arthroplasty Replacement, Knee and Arthroplasty Total Hip Replacement, run by Solventum US LLC at 2 sites in United States.
Trial summary
The goal of this clinical study is to generate data on the intended use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape. The study includes subjects undergoing primary hip or knee arthroplasty procedures. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Arthroplasty Replacement, Knee, Arthroplasty Total Hip Replacement
- What is being tested?
- 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2026to Oct 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 22 years of age on the day of surgery.
- Subject is scheduled to undergo a unilateral primary arthroplasty procedure on a hip or knee.
- Subject is capable of providing informed consent.
- Subject is willing and able to return for all visits.
Who cannot join
- Subject is pregnant or lactating prior to surgery.*
- Women who have had surgical sterilization by a medically accepted method (e.g., tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing
- Subject is scheduled to undergo a lower extremity bilateral arthroplasty procedure.
- Subject had a previous open knee surgery on the study knee or is scheduled to undergo a revision knee arthroplasty.
- Subject has had a previous surgery for revision femoral acetabular osteotomy or total hip arthroplasty on the study hip.
- Subject is scheduled for lower extremity arthroplasty due to trauma.
Show all 10Show fewer
- Subject was previously diagnosed with septic arthritis or has a history of infection in the joint.
- Subject has taken any antibiotics within 4 weeks before surgery.
- Subject has an allergy or sensitivity to components of the device (e.g., chlorhexidine gluconate or acrylate-based adhesive).
- Subject is currently enrolled in another trial.
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
Indiana University Health (IU Health)
Fishers, Indiana, 46037
Leonard T Buller, MD
- Recruiting
University of Utah Health - Department of Orthopedics
Salt Lake City, Utah, 84108
Jeremy Gililland, MD
About this study
The goal of this clinical study is to generate data on the intended use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape. The study includes subjects undergoing primary hip or knee arthroplasty procedures.
The study evaluates the intraoperative performance and safety of the incise drape during surgery, including assessment of contamination and operative characteristics.
Participants will have a CHG-impregnated antimicrobial incise drape applied during their surgical procedure. During surgery, samples will be collected from the operative site to assess potential bacterial contamination.
Read the detailed description
This is a prospective, single-arm clinical study conducted in the United States in subjects undergoing primary hip or knee arthroplasty. The study evaluates the intraoperative performance and safety of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape used during lower extremity orthopedic surgery.
Safety and intraoperative performance outcomes will be assessed throughout the study.
- Being tested
- 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
- Keywords
- Chlorohexidine Gluconate, Incise drape, CHG, Ioban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)Device
A CHG-impregnated antimicrobial incise drape applied to the surgical site prior to incision during primary hip or knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Single Treatment Arm | Experimental | 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. Receives: Device: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the presence of contamination at the surgical site during the operative procedure.
Assessment of contamination at the surgical site during the operative procedure.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start19 Feb 2026
- Primary completion4 Sep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty Replacement, KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356323
- Sponsor's protocol ID
- EM-05-015132
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07356323
- Acronym / sponsor ID
- EM-05-015132
- Keywords
- Chlorohexidine Gluconate, Incise drape, CHG, Ioban
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Jan 2026 (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 goal of this clinical study is to generate data on the intended use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape. The study includes subjects undergoing primary hip or knee arthroplasty procedures.
The study evaluates the intraoperative performance and safety of the incise drape during surgery, including assessment of contamination and operative characteristics.
Participants will have a CHG-impregnated antimicrobial incise drape applied during their surgical procedure. During surgery, samples will be collected from the operative site to assess potential bacterial contamination.
Detailed description
This is a prospective, single-arm clinical study conducted in the United States in subjects undergoing primary hip or knee arthroplasty. The study evaluates the intraoperative performance and safety of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape used during lower extremity orthopedic surgery.
Safety and intraoperative performance outcomes will be assessed throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Treatment Arm | Experimental | Device: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 22 years of age on the day of surgery.
- Subject is scheduled to undergo a unilateral primary arthroplasty procedure on a hip or knee.
- Subject is capable of providing informed consent.
- Subject is willing and able to return for all visits.
Key exclusion criteria (10 listed)
- Subject is pregnant or lactating prior to surgery.*
- Women who have had surgical sterilization by a medically accepted method (e.g., tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing
- Subject is scheduled to undergo a lower extremity bilateral arthroplasty procedure.
- Subject had a previous open knee surgery on the study knee or is scheduled to undergo a revision knee arthroplasty.
- Subject has had a previous surgery for revision femoral acetabular osteotomy or total hip arthroplasty on the study hip.
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 |
|---|---|---|
| 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)A CHG-impregnated antimicrobial incise drape applied to the surgical site prior to incision during primary hip or knee arthroplasty. | Device | Single Treatment Arm |
Primary outcome
Evaluation of the presence of contamination at the surgical site during the operative procedure.
Time frame: During surgery
Assessment of contamination at the surgical site during the operative procedure.
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG) in people with Arthroplasty Replacement, Knee and Arthroplasty Total Hip Replacement, run by Solventum US LLC 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 4 inclusion and 10 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 1 Jul 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 Tracy E Swanson (6125417752, tswanson@solventum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the presence of contamination at the surgical site during the operative procedure. (time frame: During surgery). 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 1 Jul 2026.