Trial · NCT04218110
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
NCT04218110, Phase 3, Completed, Professional Disposables International, Inc.; results first posted 2021-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances. Trials, record NCT04218110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04218110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
- NCT number
- NCT04218110
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 329 participants, actual
- Lead sponsor
- Professional Disposables International, Inc.
- Conditions
- Surgical Site Infection
- Interventions
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Prevantics 3.15 % / 70 % Swabstick
- First posted
- 2020-01-06
- Last updated
- 2021-10-22
- Results first posted
- 2021-10-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Bacterial Microflora in the Inguinal Area | 10 minutes | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention |
| Secondary | Change in Bacterial Microflora in the Inguinal Area | 30 seconds | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention |
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 | Change in Bacterial Microflora in the Inguinal Area | 10 minutes | The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body). | log10 CFU | MEAN |
| SECONDARY | Change in Bacterial Microflora in the Inguinal Area | 30 seconds | The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body). | log10 CFU | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Bacterial Microflora in the Inguinal Area | Project X 26ml | -3.86 | Standard Deviation 1.58 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Project X 10.5ml | -4.34 | Standard Deviation 1.48 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Project X 5.1ml | -3.65 | Standard Deviation 1.36 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Prevantics Maxi Swabstick | -3.80 | Standard Deviation 1.42 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Project X 26ml | -3.86 | Standard Deviation 1.55 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Project X 10.5ml | -3.76 | Standard Deviation 1.36 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Project X 5.1ml | -3.70 | Standard Deviation 1.58 | log10 CFU | |
| Change in Bacterial Microflora in the Inguinal Area | Prevantics Maxi Swabstick | -3.76 | Standard Deviation 1.48 | log10 CFU |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Project X 26ml | 82 | |
| Overall Study | STARTED | Project X 10.5ml | 81 | |
| Overall Study | STARTED | Project X 5.1ml | 83 | |
| Overall Study | STARTED | Prevantics Maxi Swabstick | 83 | |
| Overall Study | Received Treatment | Project X 26ml | 82 | |
| Overall Study | Received Treatment | Project X 10.5ml | 81 | |
| Overall Study | Received Treatment | Project X 5.1ml | 83 | |
| Overall Study | Received Treatment | Prevantics Maxi Swabstick | 82 | |
| Overall Study | COMPLETED | Project X 26ml | 82 | |
| Overall Study | COMPLETED | Project X 10.5ml | 81 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Adverse Event | Pregnancy, puerperium and perinatal conditions | Project X 26ml | 0 | 82 | 0 |
| other | Adverse Event | Pregnancy, puerperium and perinatal conditions | Project X 10.5ml | 0 | 81 | 0 |
| other | Adverse Event | Pregnancy, puerperium and perinatal conditions | Project X 5.1ml | 0 | 83 | 0 |
| other | Adverse Event | Pregnancy, puerperium and perinatal conditions | Prevantics Maxi Swabstick | 0 | 82 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Project X 26ml | 0 | 82 |
| Total, all-cause mortality | Project X 10.5ml | 0 | 81 |
| Total, all-cause mortality | Project X 5.1ml | 0 | 83 |
| Total, all-cause mortality | Prevantics Maxi Swabstick | 0 | 82 |
| Total, other adverse events | Project X 26ml | 0 | 82 |
| Total, other adverse events | Project X 10.5ml | 0 | 81 |
| Total, other adverse events | Project X 5.1ml | 0 | 83 |
| Total, other adverse events | Prevantics Maxi Swabstick | 0 | 82 |
| Total, serious adverse events | Project X 26ml | 0 | 82 |
| Total, serious adverse events | Project X 10.5ml | 0 | 81 |
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/NCT04218110
GET https://conductscience.org/api/trials/v1/NCT04218110/registered