Phase 3
N=1,388
Preoperative CHG Cloth on Healthy Subjects
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02291601 ↗Enrolled (actual)
1,388
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites — 80; 75; 86; 65 % of Treated Sites
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chlorhexidine Gluconate (Drug); Vehicle (Other); DynaHex-2 (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites |
80; 75; 86; 65; 81; 68 | — |
Summary
Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.
Eligibility Criteria
Inclusion Criteria
- Males or Females
- 16 years of age or older
- Signed informed consent
- Good Health
- Six inches of abdomen and groin areas without tattoos, or skin disorders
Exclusion Criteria
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG
Data sourced from ClinicalTrials.gov (NCT02291601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.