Trial · NCT00290290
Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
NCT00290290, Phase 3, Completed, Baylor College of Medicine; results first posted 2014-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections. Trials, record NCT00290290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00290290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
- NCT number
- NCT00290290
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 849 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Postoperative Wound Infection
- Interventions
- chlorhexidine-alcohol, Povidone-Iodine
- First posted
- 2006-02-13
- Last updated
- 2014-09-18
- Results first posted
- 2014-08-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds. | during surgery and within the 30 days post surgery | The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds. | during surgery and within the 30 days post surgery | Percentage of Post Operative Infections | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds. | Povidone-Iodine | 16.1 | 0.41 to 0.85 | Percentage of Post Operative Infections | |
| The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds. | Chlorhexidine-Alcohol | 9.5 | 0.41 to 0.85 | Percentage of Post Operative Infections |
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 | Povidone-Iodine | 440 | |
| Overall Study | STARTED | Chlorhexidine-Alcohol | 409 | |
| Overall Study | COMPLETED | Povidone-Iodine | 422 | |
| Overall Study | COMPLETED | Chlorhexidine-Alcohol | 391 | |
| Overall Study | NOT COMPLETED | Povidone-Iodine | 18 | |
| Overall Study | NOT COMPLETED | Chlorhexidine-Alcohol | 18 |
Source ClinicalTrials.gov
Adverse 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 | Pruritis/Erythema | Skin and subcutaneous tissue disorders | Povidone-Iodine | 3 | 440 | 3 |
| other | Pruritis/Erythema | Skin and subcutaneous tissue disorders | Chlorhexidine-Alcohol | 3 | 409 | 3 |
| serious | Death | Surgical and medical procedures | Povidone-Iodine | 3 | 440 | 3 |
| serious | Death | Surgical and medical procedures | Chlorhexidine-Alcohol | 4 | 409 | 4 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Povidone-Iodine | ||
| Total, all-cause mortality | Chlorhexidine-Alcohol | ||
| Total, other adverse events | Povidone-Iodine | 3 | 440 |
| Total, other adverse events | Chlorhexidine-Alcohol | 3 | 409 |
| Total, serious adverse events | Povidone-Iodine | 3 | 440 |
| Total, serious adverse events | Chlorhexidine-Alcohol | 4 | 409 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20054046 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Povidone-Iodine vs Chlorhexidine-Alcohol: serious adverse events |
Source Trial comparisons
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/NCT00290290
GET https://conductscience.org/api/trials/v1/NCT00290290/registered