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NCT03414762 · ClinicalTrials.gov registry record · Phase 3
PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
A Phase 3 study of Cesarean Section Complications and Cesarean Wound; Dehiscence, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
- 1
- Study location
NCT03414762: Completed Phase 3 study of Cesarean Section Complications and Cesarean Wound; Dehiscence, sponsored by Northwell Health.
NCT03414762 is a Phase 3 study of Cesarean Section Complications and Cesarean Wound; Dehiscence that has completed, run by Northwell Health. The registered enrollment target is 153 participants, below the 756-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03414762, a Phase 3 study of Cesarean Section Complications and Cesarean Wound; Dehiscence, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
- 1
- Study location
Study Summary
A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3 interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing elective cesarean delivery whose wounds were dressed with the PICO Negative Pressure Wound Therapy (NPWT) versus the standard dressing. We hypothesize that the PICO NPWT will reduce the incidence of surgical site occurrences and interventions and postoperative readmissions in obese women. The study will compare surgical site occurrences and surgical incision intervention incidence within 42 +/- 10 days post cesarean delivery in obese women who have the current standard-of-care dressing versus the PICO NPWT.
Primary Outcome
The incidence of postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) post Cesarean Section.The incidence of postoperative surgical site occurrences (SSOs) post Cesarean delivery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)
Conditions Studied
Interventions
- DEVICE PICO Negative Pressure Wound Therapy
- DEVICE Standard Dressing
Study Locations (1)
New York
- Long Island Jewish Medical Center - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 3 |
What the finished NCT03414762 record still lists
NCT03414762 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 756-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Cesarean Section Complications appearing as the primary indexed condition, and to 2 interventions - of which PICO Negative Pressure Wound Therapy is the first listed.
NCT03414762 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03414762 about?
NCT03414762 is a clinical study titled "PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.". A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3 interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing elective cesarean delivery whose wounds were dressed with the PICO Negative Pressure Wound Therapy (NPWT) versus the ...
What is the current status of trial NCT03414762?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2019-04-01. Estimated completion is 2022-09-30.
What conditions does trial NCT03414762 study?
This clinical trial studies the following conditions: Cesarean Section Complications, Cesarean Wound; Dehiscence, Cesarean Wound Disruption.
What interventions are being tested in trial NCT03414762?
The interventions under investigation include: PICO Negative Pressure Wound Therapy (DEVICE), Standard Dressing (DEVICE).
Who is sponsoring clinical trial NCT03414762?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03414762 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cesarean Section Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03414762's enrollment target sits among peer trials
153 4th of 9 higher than 6 of 9 other Cesarean Section Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cesarean Section Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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