Trial · NCT04756154
Efficacy Study of Patient Preoperative Preps In-vivo
NCT04756154, Phase 3, Completed, Solventum US LLC; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Study of Patient Preoperative Preps In-vivo. Trials, record NCT04756154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04756154
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Patient Preoperative Preps In-vivo
- NCT number
- NCT04756154
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 154 participants, actual
- Lead sponsor
- Solventum US LLC
- Conditions
- Surgical Skin Preparation
- Interventions
- CHG/IPA Surgical skin preparation, Normal saline
- First posted
- 2021-02-16
- Last updated
- 2024-10-01
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | 10 minutes | Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora |
| Primary | Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | 6 hours | Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora |
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 | Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | 10 minutes | 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 5.00 log10/cm\^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants. | Log10 CFU/cm^2 | MEAN |
| PRIMARY | Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | 6 hours | 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 5.00 log10/cm\^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants. | 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 |
|---|---|---|---|---|---|
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | CHG/IPA Surgical Skin Preparation | 3.60 | Standard Deviation 0.816 | Log10 CFU/cm^2 | |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | CHG/IPA Film-Forming Surgical Skin Preparation: | 3.61 | Standard Deviation 0.837 | Log10 CFU/cm^2 | |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | Normal Saline | 1.15 | Standard Deviation 0.411 | Log10 CFU/cm^2 | |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | CHG/IPA Surgical Skin Preparation | 1.98 | Standard Deviation 0.806 | Log10 CFU/cm^2 | |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | CHG/IPA Film-Forming Surgical Skin Preparation | 2.40 | Standard Deviation 0.792 | Log10 CFU/cm^2 | |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | Normal Saline | 1.03 | Standard Deviation 0.443 | Log10 CFU/cm^2 |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CHG/IPA Surgical Skin Preparation | 135 | 135 |
| Overall Study | STARTED | CHG/IPA Film-Forming Surgical Skin Preparation | 135 | 135 |
| Overall Study | STARTED | Normal Saline | 38 | 38 |
| Overall Study | COMPLETED | CHG/IPA Surgical Skin Preparation | 104 | 104 |
| Overall Study | COMPLETED | CHG/IPA Film-Forming Surgical Skin Preparation | 106 | 106 |
| Overall Study | COMPLETED | Normal Saline | 31 | 31 |
| Overall Study | NOT COMPLETED | CHG/IPA Surgical Skin Preparation | 31 | 31 |
| Overall Study | NOT COMPLETED | CHG/IPA Film-Forming Surgical Skin Preparation | 29 | 29 |
| Overall Study | NOT COMPLETED | Normal Saline | 7 | 7 |
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 | CHG/IPA Surgical Skin Preparation | 0 | 135 |
| Total, all-cause mortality | CHG/IPA Film-Forming Surgical Skin Preparation | 0 | 135 |
| Total, all-cause mortality | Normal Saline | 0 | 38 |
| Total, other adverse events | CHG/IPA Surgical Skin Preparation | 0 | 135 |
| Total, other adverse events | CHG/IPA Film-Forming Surgical Skin Preparation | 0 | 135 |
| Total, other adverse events | Normal Saline | 0 | 38 |
| Total, serious adverse events | CHG/IPA Surgical Skin Preparation | 0 | 135 |
| Total, serious adverse events | CHG/IPA Film-Forming Surgical Skin Preparation | 0 | 135 |
| Total, serious adverse events | Normal Saline | 0 | 38 |
Source ClinicalTrials.gov
Papers0
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/NCT04756154
GET https://conductscience.org/api/trials/v1/NCT04756154/registered