Trial · NCT03009110
Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
NCT03009110, Not applicable, Terminated, Indiana University; results first posted 2023-06-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial. Trials, record NCT03009110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03009110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
- NCT number
- NCT03009110
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 1,624 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Surgical Wound Infection, Cesarean Section
- Interventions
- Prophylactic NPWT, Standard Dressing
- First posted
- 2017-01-04
- Last updated
- 2023-06-01
- Results first posted
- 2023-06-01
- Limitations and caveats
The trial was stopped following a planned interim analysis, raising the possibility that it may be underpowered.~The clinical team could not be blinded to the intervention, raising the possibility of bias.~No adjustment was made for multiple comparisons, thus secondary end points could have occurred by chance.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) | 30 days postoperatively | As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria. |
| Secondary | Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | 30 days postoperatively | As defined according to the CDC's National Healthcare Safety Network criteria. |
| Secondary | Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | 30 days postoperatively | As defined according to the CDC's National Healthcare Safety Network criteria. |
| Secondary | Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | 30 days postoperatively | Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more). |
| Secondary | Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | 30 days postoperatively | Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more). |
| Secondary | Patient Pain Score | At discharge, an average of 4 days postoperatively | On a scale of 0 (least) - 10 (most). |
| Secondary | Patient Pain Score | At postoperative day 30 | On a scale of 0 (least) - 10 (most). |
| Secondary | Patient Satisfaction Score | At discharge, an average of 4 days postoperatively | On a scale of 0 (least) - 10 (most). |
| Secondary | Patient Satisfaction Score | At postoperative day 30 | On a scale of 0 (least) - 10 (most). |
| Secondary | Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization) | 30 days postoperatively | Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 Superficial or Deep Surgical Site Infections (SSIs) | 30 days postoperatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | 30 days postoperatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | 30 days postoperatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | 30 days postoperatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | 30 days postoperatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient Pain Score | At discharge, an average of 4 days postoperatively | score on a scale | MEDIAN | |
| SECONDARY | Patient Pain Score | At postoperative day 30 | score on a scale | MEDIAN | |
| SECONDARY | Patient Satisfaction Score | At discharge, an average of 4 days postoperatively | score on a scale | MEDIAN | |
| SECONDARY | Patient Satisfaction Score | At postoperative day 30 | score on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization) | 30 days postoperatively | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults 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 Superficial or Deep Surgical Site Infections (SSIs) | Prophylactic NPWT | 29 | Participants | ||
| Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) | Standard Dressing | 27 | Participants | ||
| Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | Prophylactic NPWT | 29 | Participants | ||
| Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | Standard Dressing | 27 | Participants | ||
| Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | Prophylactic NPWT | 2 | Participants | ||
| Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | Standard Dressing | 2 | Participants | ||
| Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | Prophylactic NPWT | 21 | Participants | ||
| Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | Standard Dressing | 25 | Participants | ||
| Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | Prophylactic NPWT | 52 | Participants | ||
| Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | Standard Dressing | 54 | 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 | Prophylactic NPWT | 816 | |
| Overall Study | STARTED | Standard Dressing | 808 | |
| Overall Study | COMPLETED | Prophylactic NPWT | 806 | |
| Overall Study | COMPLETED | Standard Dressing | 802 | |
| Overall Study | NOT COMPLETED | Prophylactic NPWT | 10 | |
| Overall Study | NOT COMPLETED | Standard Dressing | 6 |
Source ClinicalTrials.gov
Adverse events14
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 | Blisters | Skin and subcutaneous tissue disorders | Prophylactic NPWT | 27 | 806 | 27 |
| other | Blisters | Skin and subcutaneous tissue disorders | Standard Dressing | 2 | 802 | 2 |
| other | Bleeding | Blood and lymphatic system disorders | Prophylactic NPWT | 9 | 806 | 9 |
| other | Bleeding | Blood and lymphatic system disorders | Standard Dressing | 0 | 802 | 0 |
| other | Erythema | Skin and subcutaneous tissue disorders | Prophylactic NPWT | 10 | 806 | 10 |
| other | Erythema | Skin and subcutaneous tissue disorders | Standard Dressing | 3 | 802 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | Prophylactic NPWT | 14 | 806 | 14 |
| other | Rash | Skin and subcutaneous tissue disorders | Standard Dressing | 1 | 802 | 1 |
| serious | Maternal ICU admission | Skin and subcutaneous tissue disorders | Prophylactic NPWT | 1 | 806 | 1 |
| serious | Maternal ICU admission | Skin and subcutaneous tissue disorders | Standard Dressing | 2 | 802 | 2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prophylactic NPWT | 0 | 806 |
| Total, all-cause mortality | Standard Dressing | 0 | 802 |
| Total, other adverse events | Prophylactic NPWT | 56 | 806 |
| Total, other adverse events | Standard Dressing | 5 | 802 |
| Total, serious adverse events | Prophylactic NPWT | 4 | 806 |
| Total, serious adverse events | Standard Dressing | 5 | 802 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD086007 | Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: Multicenter Randomized Trial | TUULI, METHODIUS GAMUO; HARPER, LORIE M | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2019 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prophylactic NPWT vs Standard Dressing: Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events) | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: deaths from any cause | Trial comparisons |
Prophylactic NPWT vs Standard Dressing: Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization) | Trial comparisons |
| Prophylactic NPWT vs Standard Dressing: 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/NCT03009110
GET https://conductscience.org/api/trials/v1/NCT03009110/results?page=2