Clinical Evaluation of Patient Preoperative Prep
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02831816|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Surgical Skin Preparation||Drug: ZP Drug: ChloraPrep Drug: ZP Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation|
|Actual Study Start Date :||August 3, 2016|
|Actual Primary Completion Date :||August 3, 2017|
|Actual Study Completion Date :||August 3, 2017|
Experimental: ZP (70% IPA)
Isopropyl alcohol (IPA) 70%
Other Name: Isopropyl alcohol 70%
Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Placebo Comparator: ZP Vehicle
ZP without IPA
Drug: ZP Vehicle
Other Name: ZP without IPA
- Bacterial reduction [ Time Frame: 10 minutes post product application ]A 2-log per cm2 bacterial reduction on the abdomen region and a 3-log per cm2 reduction on the inguinal region is considered a success.
- Skin Irritation [ Time Frame: 30 seconds to 6 hours ]Safety as assessed by Skin Irritation score (erythema, edema, rash, dryness) of 0-3.
- Bacterial reduction [ Time Frame: 30 seconds post product application ]A 2-log per cm2 bacterial reduction on the abdomen region and a 3-log per cm2 reduction on the inguinal region is considered a success.
- Bacterial reduction [ Time Frame: 6 hours post product application ]Skin flora does not return to baseline on the abdomen and inguinal region is considered a success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831816
|United States, Montana|
|BioScience Laboratories, Inc.|
|Bozeman, Montana, United States, 59718|