Clinical trial
Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions
Name
EM-05-013509
Description
The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
Trial arms
Trial start
2015-03-01
Estimated PCD
2015-04-01
Trial end
2015-04-01
Status
Completed
Phase
Early phase I
Treatment
3M CHG/IPA Surgical Skin Preparation - Abdominal Region
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Arms:
3M CHG/IPA - Abdominal Region
Other names:
SoluPrep
Normal Saline - Abdominal Region
0.9% sodium chloride applied with foam applicator
Arms:
Normal Saline - Abdominal Region
3M CHG/IPA Surgical Skin Preparation - Inguinal Region
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Arms:
3M CHG/IPA - Inguinal Region
Other names:
SoluPrep
Normal Saline - Inguinal Region
0.9% sodium chloride applied with foam applicator
Arms:
Normal Saline - Inguinal Region
Size
27
Primary endpoint
Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
Baseline, 48 hours and 72 hours post-prep application
Eligibility criteria
Inclusion Criteria:
* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin
Exclusion Criteria:
* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}
Updated at
2023-06-07
1 organization
1 product
1 indication
Organization
3M