Trial · NCT03155178
In Vivo Preoperative Skin Preparation Persistence Evaluation
NCT03155178, Phase 2, Completed, Solventum US LLC; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. In Vivo Preoperative Skin Preparation Persistence Evaluation. Trials, record NCT03155178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03155178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- In Vivo Preoperative Skin Preparation Persistence Evaluation
- NCT number
- NCT03155178
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- Solventum US LLC
- Conditions
- Bacterial Recovery of Skin Flora Post-product Application
- Interventions
- 3M CHG/IPA Prep, ChloraPrep
- First posted
- 2017-05-16
- Last updated
- 2024-10-02
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of Skin Flora Recovery Post-prep Application | Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times. |
| Secondary | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment | Log10 CFU/cm\^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm\^2, at 3 defined post-treatment sampling times. |
| Other | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment | Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of Skin Flora Recovery Post-prep Application | Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or \> or equal to 5.0 log10 CFU/cm\^2 on the inguinal test site. | log10 CFU/cm^2 | MEAN |
| SECONDARY | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment | The secondary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or 5.0 log10 CFU/cm\^2 on the inguinal test | log10 CFU/cm^2 | MEAN |
| OTHER_PRE_SPECIFIED | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment | Subjects meeting required baseline counts: greater or equal to 3.00 log10 CFU/cm\^2 on the abdominal region and greater than or or equal to 5.00 log10 CFU/cm\^2 on the inguinal region. | sites | NUMBER |
Source ClinicalTrials.gov
Results by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of Skin Flora Recovery Post-prep Application | Experimental Prep - Abdominal Site | 48 hour timepoint | 1.39 | Standard Deviation 1.27 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Active Comparator Prep - Abdominal Site | 48 hour timepoint | 1.15 | Standard Deviation 1.02 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Experimental Prep - Inguinal Site | 48 hour timepoint | 1.97 | Standard Deviation 1.19 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Active Comparator Prep - Inguinal Site | 48 hour timepoint | 1.82 | Standard Deviation 1.10 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Experimental Prep - Abdominal Site | 72 hour timepoint | 0.89 | Standard Deviation 1.11 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Active Comparator Prep - Abdominal Site | 72 hour timepoint | 0.92 | Standard Deviation 1.05 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Experimental Prep - Inguinal Site | 72 hour timepoint | 1.94 | Standard Deviation 1.41 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Active Comparator Prep - Inguinal Site | 72 hour timepoint | 2.13 | Standard Deviation 1.30 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Experimental Prep - Abdominal Site | 96 hour timepoint | 1.21 | Standard Deviation 1.20 | log10 CFU/cm^2 |
| Measurement of Skin Flora Recovery Post-prep Application | Active Comparator Prep - Abdominal Site | 96 hour timepoint | 1.17 | Standard Deviation 1.18 | log10 CFU/cm^2 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 3M CHG/IPA Prep/Abdominal Region | 69 | 69 |
| Overall Study | STARTED | ChloraPrep/Abdominal Region | 69 | 69 |
| Overall Study | STARTED | 3M CHG/IPA Prep/Inguinal Region | 69 | 69 |
| Overall Study | STARTED | ChloraPrep/Inguinal Region | 69 | 69 |
| Overall Study | COMPLETED | 3M CHG/IPA Prep/Abdominal Region | 62 | 62 |
| Overall Study | COMPLETED | ChloraPrep/Abdominal Region | 62 | 62 |
| Overall Study | COMPLETED | 3M CHG/IPA Prep/Inguinal Region | 62 | 62 |
| Overall Study | COMPLETED | ChloraPrep/Inguinal Region | 62 | 62 |
| Overall Study | NOT COMPLETED | 3M CHG/IPA Prep/Abdominal Region | 7 | 7 |
| Overall Study | NOT COMPLETED | ChloraPrep/Abdominal Region | 7 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 3M CHG/IPA Prep Abdominal Region | 0 | 69 |
| Total, all-cause mortality | ChloraPrep CHG/IPA Abdominal Region | 0 | 69 |
| Total, all-cause mortality | 3M CHG/IPA Prep Inguinal Region | 0 | 69 |
| Total, all-cause mortality | ChloraPrep CHG/IPA Inguinal Region | 0 | 69 |
| Total, other adverse events | 3M CHG/IPA Prep Abdominal Region | 0 | 69 |
| Total, other adverse events | ChloraPrep CHG/IPA Abdominal Region | 0 | 69 |
| Total, other adverse events | 3M CHG/IPA Prep Inguinal Region | 0 | 69 |
| Total, other adverse events | ChloraPrep CHG/IPA Inguinal Region | 0 | 69 |
| Total, serious adverse events | 3M CHG/IPA Prep Abdominal Region | 0 | 69 |
| Total, serious adverse events | ChloraPrep CHG/IPA Abdominal Region | 0 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03155178
GET https://conductscience.org/api/trials/v1/NCT03155178/results?page=2