A Phase 3 interventional study of CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). and CHG 2% w/v & IPA 70% v/v swab applied sequentially in Topical Antisepsis, sponsored by C. R. Bard. Completed at 1 site in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by C. R. Bard · Phase 3, Interventional, and Other
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.
Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.
C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time
Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).
Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially
Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially
Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base
Drug: Aqueous CHG 4% w/v applied according to mfr's directions
Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.
Other: Sterile swabstick with sterile water (3 @ once)
Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.
Other: Sterile swabstick with sterile water (one-at-a-time)
3 swabsticks topically applied at the same time to intact skin
Also known as: ChloraPrep Swabstick
Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.
Also known as: ChloraPrep Swabstick
Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
Also known as: Hibiclens
3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
Time frame: 10 minutes and 6 hours after application of test solutions
| Milestone | All Study Participants |
|---|---|
| Started | 335 |
| Chg swabstick (3 @ once) | 139 |
| Chg swabstick sequential | 138 |
| Hibiclens | 133 |
| Sterile water swab (3 @ once) | 132 |
| Sterile water swabstick (sequential) | 126 |
| Completed | 335 |
| Not completed | 0 |
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
| Average log10 reductions in CFU/cm2 | CHG Swabstick (3 @ Once) | CHG Swabstick Sequential | Hibiclens | Sterile Water Swab (3 @ Once) | Sterile Water Swabstick (Sequential) |
|---|---|---|---|---|---|
| Groin site - 10 minutes | 3.51 ± 0.62 | 3.44 ± 0.64 | 3.15 ± 0.53 | 0.92 ± 0.47 | 0.97 ± 0.55 |
| Groin site - 6 hours | 3.22 ± 0.65 | 3.24 ± 0.58 | 2.89 ± 0.62 | 0.82 ± 0.47 | 0.85 ± 0.58 |
| Abdomen site - 10 minutes | 2.56 ± 0.50 | 2.58 ± 0.48 | 2.76 ± 0.49 | 0.54 ± 0.37 | 0.50 ± 0.35 |
| Abdomen site - 6 hours | 2.38 ± 0.60 | 2.39 ± 0.64 | 2.51 ± 0.66 | 0.47 ± 0.38 | 0.46 ± 0.39 |
Collected over During the study through the 6-hour time point evaluations. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHG Swabstick (3 @ Once) | 0/139 (0%) | 0/139 (0%) | 0/139 (0%) |
| CHG Swabstick Sequential | 0/138 (0%) | 0/138 (0%) | 0/138 (0%) |
| Hibiclens | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
| Sterile Water Swab (3 @ Once) | 0/132 (0%) | 0/132 (0%) | 0/132 (0%) |
| Sterile Water Swabstick (Sequential) | 0/126 (0%) | 0/126 (0%) | 0/126 (0%) |
Participants treated in the study with adequate baseline bacterial load.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 34.9 ± 14.1 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| All Participants — Female | 149 |
| All Participants — Male | 186 |
| 371-121 Preoperative Skin Preparations(Participants) | All Study Participants |
|---|---|
| CHG Swabstick (3 @ Once) | 139 |
| CHG Swabstick (Sequential) | 138 |
| Hibiclens | 133 |
| Sterile Water Swab (3 @ Once) | 132 |
| Sterile Water Swabstick (Sequential) | 126 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
C. R. Bard