Trial · NCT02831816
Clinical Evaluation of Patient Preoperative Prep
NCT02831816, Phase 3, Completed, Zurex Pharma, Inc.; results first posted 2021-07-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Evaluation of Patient Preoperative Prep. Trials, record NCT02831816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02831816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Evaluation of Patient Preoperative Prep
- NCT number
- NCT02831816
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 640 participants, actual
- Lead sponsor
- Zurex Pharma, Inc.
- Conditions
- Surgical Skin Preparation
- Interventions
- ZuraPrep, ChloraPrep, ZP Vehicle
- First posted
- 2016-07-13
- Last updated
- 2021-07-16
- Results first posted
- 2021-07-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bacterial Reduction | 10 minutes post product application | A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success. |
| Primary | Bacterial Reduction - Abdomen | 10 minutes post product application | A 2-log per cm2 bacterial reduction on the abdomen region is considered a success. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bacterial Reduction | 10 minutes post product application | Treated subjects with treatment day baseline criteria 5.0-7.5 log recoveries. | log10 cfu/cm^2 | MEAN |
| PRIMARY | Bacterial Reduction - Abdomen | 10 minutes post product application | Treated subjects with treatment day baseline criteria 3.0-5.5 log10 recoveries. | log10 cfu/cm^2 | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bacterial Reduction | Mean Log Reduction - ZP (70% IPA) - Groin | 4.04 | Standard Deviation 1.33 | log10 cfu/cm^2 | |
| Bacterial Reduction | Mean Log Reduction - Groin - ChloraPrep | 4.01 | Standard Deviation 1.43 | log10 cfu/cm^2 | |
| Bacterial Reduction | Mean Log Reduction - Groin - ZP Vehicle | 1.60 | Standard Deviation 0.69 | log10 cfu/cm^2 | |
| Bacterial Reduction - Abdomen | Mean Log Reduction - ZP (70% IPA) - Abdomen | 2.99 | Standard Deviation 1.1 | log10 cfu/cm^2 | |
| Bacterial Reduction - Abdomen | Mean Log Reduction - Abdomen - ChloraPrep | 2.79 | Standard Deviation 1.1 | log10 cfu/cm^2 | |
| Bacterial Reduction - Abdomen | Mean Log Reduction - Abdomen - ZP Vehicle | 1.00 | Standard Deviation 0.9 | log10 cfu/cm^2 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 640 | 640 |
| Overall Study | ZP | All Participants | 589 | 589 |
| Overall Study | CP | All Participants | 590 | 590 |
| Overall Study | Vehicle | All Participants | 131 | 131 |
| Overall Study | COMPLETED | All Participants | 640 | 640 |
| Overall Study | NOT COMPLETED | All Participants | 0 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZP (70% IPA) | 0 | 589 |
| Total, all-cause mortality | ChloraPrep | 0 | 590 |
| Total, all-cause mortality | ZP Vehicle | 0 | 131 |
| Total, other adverse events | ZP (70% IPA) | 0 | 589 |
| Total, other adverse events | ChloraPrep | 0 | 590 |
| Total, other adverse events | ZP Vehicle | 0 | 131 |
| Total, serious adverse events | ZP (70% IPA) | 0 | 589 |
| Total, serious adverse events | ChloraPrep | 0 | 590 |
| Total, serious adverse events | ZP Vehicle | 0 | 131 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32131912 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02831816
GET https://conductscience.org/api/trials/v1/NCT02831816/registered