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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 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.

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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.

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

FieldValue
Enrollment Target 153 participants
Start Date 2019-04-01
Est. Completion 2022-09-30
Phase Phase 3

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT03414762

The ClinicalTrials.gov registry entry for NCT03414762 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 756-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (80% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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