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ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.
The single investigational test article, ZuraPrep solution is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin.
The primary objective of this study is to characterize the in vivo effects of the ZuraPrep test article compared to the positive reference control ChloraPrep, as well as to evaluate the ZuraPrep test vehicle to the negative control, Saline, using the newly proposed sampling intervals.
This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Treatments will be evaluated at 30 seconds, 10 minutes and 6 hour sampling intervals compared to baseline. Status will be calculated separately for the abdomen and groin for each side of the body.
Study duration for subjects - 3 to 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZuraPrep with 70% Isopropyl alcohol | Experimental | Test Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep |
|
| ZuraPrep without 70% IPA | Experimental | Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline |
|
| ChloraPrep Teal Tint | Active Comparator | Test Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep [Chlorhexidine gluconate(CHG)/IPA] Teal Tint |
|
| Normal Saline 0.85% | Placebo Comparator | Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZuraPrep with 70% IPA | Drug | Apply topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment | calculated as log-10 CFU responder rates from baseline | 30 seconds |
| Reduction of skin flora measured by 1994 TFM | calculated as log-10 CFU reductions from baseline | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Skin flora measurement | The bacterial counts should not exceed baseline at the 6 hour sampling time | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Hamid Barshir, MD | MicroBioTest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MicroBioTest | Sterling | Virginia | 20164 | United States |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C547847 | citrate, isopropyl alcohol, methylene blue, parabens drug combination |
| D002864 | Chromogranins |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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| ZuraPrep without 70% IPA | Drug | Apply topically. 0% IPA |
|
|
| ChloraPrep CHG/IPA Teal Tint | Drug | Apply topically |
|
|
| Normal Saline | Other | Apply topically |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |