Trial · NCT01968707
In-vivo Efficacy Study of Patient Pre-operative Preps
NCT01968707, Phase 3, Completed, Solventum US LLC; results first posted 2021-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. In-vivo Efficacy Study of Patient Pre-operative Preps. Trials, record NCT01968707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968707
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- In-vivo Efficacy Study of Patient Pre-operative Preps
- NCT number
- NCT01968707
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 426 participants, actual
- Lead sponsor
- Solventum US LLC
- Conditions
- Bacterial Reduction on Skin Flora Post-product Application
- Interventions
- ChloraPrep Hi-Lite Orange, Normal saline, 3M CHG/IPA Prep Tint 10.5-mL, 3M CHG/IPA Prep Tint 26-mL
- First posted
- 2013-10-24
- Last updated
- 2024-10-02
- Results first posted
- 2021-06-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder Rate | baseline, 10 minutes post-product application and 6 hour post-product application | On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. |
| Secondary | Reduction of Skin Flora 6 Hours Post-treatment | 6 hours | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment |
| Secondary | Reduction of Skin Flora 10 Minutes Post-treatment | 10 minutes | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment |
| Secondary | Skin Flora Recovery 6-hours Post-treatment | 6 hours post-treatment | Log10/cm2 recovery of skin flora at 6 hours following application of study treatment |
| Secondary | Skin Flora Recovery 10 Minutes Post-treatment | 10 minutes post-treatment | Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments |
| Secondary | Skin Flora Baseline for the Abdominal and Inguinal Region. | Baseline | Log10/cm2 baseline skin flora for abdominal and inguinal regions |
| Secondary | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour 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=moderated, 3=severe |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responder Rate | baseline, 10 minutes post-product application and 6 hour post-product application | 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 on the abdomen test site or 5.0 log10 on the inguinal test site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Reduction of Skin Flora 6 Hours Post-treatment | 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 either \> or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | log10/cm2 | MEAN |
| SECONDARY | Reduction of Skin Flora 10 Minutes Post-treatment | 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 either \> or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | log10/cm2 | MEAN |
| SECONDARY | Skin Flora Recovery 6-hours Post-treatment | 6 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 on the abdomen test site or 5.0 log10 on the inguinal test site. | log10/cm2 skin flora | MEAN |
| SECONDARY | Skin Flora Recovery 10 Minutes Post-treatment | 10 minutes 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 on the abdomen test site or 5.0 log10 on the inguinal test site. | log10/cm2 skin flora | MEAN |
| SECONDARY | Skin Flora Baseline for the Abdominal and Inguinal Region. | Baseline | 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 on the abdomen test site or 5.0 log10 on the inguinal test site. | log10/cm2 skin flora | MEAN |
| SECONDARY | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment. | The primary safety analysis data set used an Intent to Treat population. | test sites on skin | NUMBER |
Source ClinicalTrials.gov
Results by group432
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder Rate | ChloraPrep Hi-Lite Orange - Abdominal | 178 | Participants | ||
| Responder Rate | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | 167 | Participants | ||
| Responder Rate | 3M CHG/IPA Prep Tint 26-mL - Abdominal | 175 | Participants | ||
| Responder Rate | Normal Saline - Abdominal | 0 | Participants | ||
| Responder Rate | ChloraPrep Hi-Lite Orange - Inguinal | 168 | Participants | ||
| Responder Rate | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | 168 | Participants | ||
| Responder Rate | 3M CHG/IPA Prep Tint 26-mL - Inguinal | 162 | Participants | ||
| Responder Rate | Normal Saline - Inguinal | 4 | Participants | ||
| Reduction of Skin Flora 6 Hours Post-treatment | ChloraPrep Hi-Lite Orange - Abdominal | 1.77 | Standard Deviation 0.899 | log10/cm2 | |
| Reduction of Skin Flora 6 Hours Post-treatment | Normal Saline - Abdominal | 0.47 | Standard Deviation 0.651 | log10/cm2 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ChloraPrep Hi-Lite Orange - Abdominal | 247 | 247 |
| Overall Study | STARTED | Normal Saline - Abdominal | 74 | 74 |
| Overall Study | STARTED | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | 246 | 246 |
| Overall Study | STARTED | 3M CHG/IPA Prep Tint 26-mL - Abdominal | 245 | 245 |
| Overall Study | STARTED | ChloraPrep Hi-Lite Orange - Inguinal | 236 | 236 |
| Overall Study | STARTED | Normal Saline - Inguinal | 70 | 70 |
| Overall Study | STARTED | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | 238 | 238 |
| Overall Study | STARTED | 3M CHG/IPA Prep Tint 26-mL - Inguinal | 238 | 238 |
| Overall Study | COMPLETED | ChloraPrep Hi-Lite Orange - Abdominal | 198 | 198 |
| Overall Study | COMPLETED | Normal Saline - Abdominal | 62 | 62 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ChloraPrep Hi-Lite Orange - Abdominal | 0 | 247 |
| Total, all-cause mortality | Normal Saline - Abdominal | 0 | 74 |
| Total, all-cause mortality | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | 0 | 246 |
| Total, all-cause mortality | 3M CHG/IPA Prep Tint 26-mL - Abdominal | 0 | 245 |
| Total, all-cause mortality | ChloraPrep Hi-Lite Orange - Inguinal | 0 | 236 |
| Total, all-cause mortality | Normal Saline - Inguinal | 0 | 70 |
| Total, all-cause mortality | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | 0 | 238 |
| Total, all-cause mortality | 3M CHG/IPA Prep Tint 26-mL - Inguinal | 0 | 238 |
| Total, other adverse events | ChloraPrep Hi-Lite Orange - Abdominal | 0 | 247 |
| Total, other adverse events | Normal Saline - Abdominal | 0 | 74 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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/NCT01968707
GET https://conductscience.org/api/trials/v1/NCT01968707/results?page=2