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NCT02578745 · ClinicalTrials.gov registry record · NA

Prophylactic Incisional Care in Obese Women at Cesarean

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
120
Enrollment target

NCT02578745: Completed NA study, sponsored by Washington University School of Medicine.

NCT02578745 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02578745, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
120 participants
Enrollment target

Study Summary

Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface - has been used to treat open wounds since the late 1990s. Experimental evidence suggests NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Although effectiveness of prophylactic NPWT is biologically plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is lacking. The objective of this pilot randomized controlled trial of 120 patients to test the hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after cesarean in obese women. The investigators will randomly assign obese women undergoing cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for Disease Control and Prevention (CDC) criteria and other wound complications (separation, hematoma, seroma) after cesarean. Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of wound complications; patient pain and satisfaction scores; physician office visit or emergency department (ED) visits for SSIs; and hospital readmission for wound complications.

Primary Outcome

Superficial or deep SSIs or other wound complications (separation, hematoma, seroma) after cesarean. SSI will be defined according to the Centers for Disease Control (CDC) criteria as infections at the surgical site occurring within 30 days of cesarean delivery, and classified as superficial, deep, or organ/space occupying.

Interventions

  • OTHER Standard Dressing
  • DEVICE Prophylactic NPWT (PICO system)

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2015-10
Est. Completion 2016-03
Phase NA

What the finished NCT02578745 record still lists

NCT02578745 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard Dressing is the first listed.

NCT02578745 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02578745 about?

NCT02578745 is a clinical study titled "Prophylactic Incisional Care in Obese Women at Cesarean". Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface - has been used to treat open wounds since the late 1990s. Experimental evidence suggests NPWT promotes wound healing ...

What is the current status of trial NCT02578745?

This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2015-10. Estimated completion is 2016-03.

What interventions are being tested in trial NCT02578745?

The interventions under investigation include: Standard Dressing (OTHER), Prophylactic NPWT (PICO system) (DEVICE).

Who is sponsoring clinical trial NCT02578745?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02578745's enrollment target sits among peer trials

120 762nd of 2000 higher than 1,198 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02578745, the US trial registry maintained by the National Library of Medicine. NCT02578745 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.