Trial · NCT02402907
STRIPES Study: Study To Reduce Infection Post cEsarean Section
NCT02402907, Not applicable, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2020-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STRIPES Study: Study To Reduce Infection Post cEsarean Section. Trials, record NCT02402907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02402907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STRIPES Study: Study To Reduce Infection Post cEsarean Section
- NCT number
- NCT02402907
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,356 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Chlorhexidine Gluconate Cloths, Infection; Cesarean Section, Infectious Morbidity, Surgical Site Infections, Endometritis
- Interventions
- 2% chlorhexidine gluconate (CHG) cloth, Placebo cloth
- First posted
- 2015-03-30
- Last updated
- 2020-11-09
- Results first posted
- 2020-11-09
- Limitations and caveats
Limitations included the lower than anticipated rate of SSIs after scheduled cesarean deliveries, suggesting the possibility that the study was underpowered for the primary outcome. High rate of private insurance may limit generalizability.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Incisional SSI | at 6 weeks | Number of participants with Incisional Surgical Site Infection (SSI) |
| Primary | Number of Adherent Participants With Incisional SSI | at 6 weeks | Among those with full adherence to the protocol and who were available for assessment at 6 weeks. Adherence to the protocol was assessed in the following 2 ways: evaluation of returned packages on the day of surgery and report ascertained by phone interview at 2 weeks. |
| Primary | Number of Participants With Endometritis | at 6 weeks | Number of participants with endometritis |
| Secondary | Number of Participants With Maternal Complications | up to 6 weeks | Number of participants with maternal complications |
| Secondary | Incidence of Neonatal ICU Admissions | up to 6 weeks | |
| Secondary | Maternal Length of Stay | at 6 weeks | Length of stay (index hospitalization) |
| Secondary | Number of Participants With Maternal Readmissions | up to 6 weeks | Number of participants with hospital readmission for wound complication |
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 | Number of Participants With Incisional SSI | at 6 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Adherent Participants With Incisional SSI | at 6 weeks | participants with full adherence to protocol and available for assessment at 6 weeks | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Endometritis | at 6 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Maternal Complications | up to 6 weeks | Data results only for those participants who underwent C-Section at Sinai | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Neonatal ICU Admissions | up to 6 weeks | Data not collected | ||
| SECONDARY | Maternal Length of Stay | at 6 weeks | data for participants who were hospitalized | days | MEDIAN |
| SECONDARY | Number of Participants With Maternal Readmissions | up to 6 weeks | Data results only for those participants who underwent C-Section at Sinai. unable to obtain data for 2 participants in placebo cloth arm | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Incisional SSI | CHG Cloth | 17 | Participants | ||
| Number of Participants With Incisional SSI | Placebo Cloth | 24 | Participants | ||
| Number of Adherent Participants With Incisional SSI | CHG Cloth | 10 | Participants | ||
| Number of Adherent Participants With Incisional SSI | Placebo Cloth | 17 | Participants | ||
| Number of Participants With Endometritis | CHG Cloth | 0 | Participants | ||
| Number of Participants With Endometritis | Placebo Cloth | 1 | Participants | ||
| Number of Participants With Maternal Complications | CHG Cloth | Erythema at operative site | 16 | Participants | |
| Number of Participants With Maternal Complications | Placebo Cloth | Erythema at operative site | 16 | Participants | |
| Number of Participants With Maternal Complications | CHG Cloth | Skin Separation | 19 | Participants | |
| Number of Participants With Maternal Complications | Placebo Cloth | Skin Separation | 23 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CHG Cloth | 682 | |
| Overall Study | STARTED | Placebo Cloth | 674 | |
| Overall Study | COMPLETED | CHG Cloth | 662 | |
| Overall Study | COMPLETED | Placebo Cloth | 647 | |
| Overall Study | NOT COMPLETED | CHG Cloth | 20 | |
| Overall Study | NOT COMPLETED | Placebo Cloth | 27 |
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CHG Cloth | 0 | 672 |
| Total, all-cause mortality | Placebo Cloth | 0 | 670 |
| Total, other adverse events | CHG Cloth | 0 | 672 |
| Total, other adverse events | Placebo Cloth | 0 | 670 |
| Total, serious adverse events | CHG Cloth | 0 | 672 |
| Total, serious adverse events | Placebo Cloth | 0 | 670 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CHG Cloth vs Placebo Cloth: Number of Adherent Participants With Incisional SSI | Trial comparisons |
| CHG Cloth vs Placebo Cloth: Number of Participants With Incisional SSI | Trial comparisons |
| CHG Cloth vs Placebo Cloth: deaths from any cause | Trial comparisons |
| CHG Cloth vs Placebo Cloth: Number of Participants With Endometritis | Trial comparisons |
| CHG Cloth vs Placebo Cloth: Number of Participants With Maternal Readmissions | Trial comparisons |
| CHG Cloth vs Placebo Cloth: serious adverse events | 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/NCT02402907
GET https://conductscience.org/api/trials/v1/NCT02402907/results?page=2