Trial of Preoperative Skin Preparation
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ClinicalTrials.gov Identifier: NCT02530541 |
Recruitment Status
:
Completed
First Posted
: August 21, 2015
Last Update Posted
: August 21, 2015
|
Sponsor:
Medline Industries
Information provided by (Responsible Party):
Medline Industries
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Brief Summary:
Pilot study to evaluate and compare activity of preoperative preparation with comparator
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: CHG | Phase 1 Phase 2 |
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: CHG 1 min
1 min application time
|
Drug: CHG
Varied application times
Other Name: Chlorhexidine Gluconate
|
Experimental: CHG 2 min
2 min application time
|
Drug: CHG
Varied application times
Other Name: Chlorhexidine Gluconate
|
Active Comparator: Comparator CHG
Marketed CHG
|
Drug: CHG
Varied application times
Other Name: Chlorhexidine Gluconate
|
Primary Outcome Measures
:
- Log Reduction of Bacterial Flora on the Abdomen and Groin [ Time Frame: 10 min, 6 hr and 8 hr ]Evaluate the Log Reduction of normal flora at various timepoints
Secondary Outcome Measures
:
- Adverse Events [ Time Frame: 10 min, 6 hr and 8 hr ]Compare the percent of treatment related adverse events
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy
- No dermatological conditions
Exclusion Criteria:
- Sensitivity to CHG
- Sensitivity to natural latex rubber or adhesive skin products
No Contacts or Locations Provided
Responsible Party: | Medline Industries |
ClinicalTrials.gov Identifier: | NCT02530541 History of Changes |
Other Study ID Numbers: |
R14-015 |
First Posted: | August 21, 2015 Key Record Dates |
Last Update Posted: | August 21, 2015 |
Last Verified: | August 2015 |
Additional relevant MeSH terms:
Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local |
Anti-Infective Agents Disinfectants Dermatologic Agents |