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NCT01450631 · ClinicalTrials.gov registry record · NA

The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions

A NA study, sponsored by KCI USA.

Completed
Registry status
NA
Development phase
92
Enrollment target

NCT01450631: Completed NA study, sponsored by KCI USA.

NCT01450631 is a NA study that has completed, run by KCI USA. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01450631, a NA study, has completed, sponsored by KCI USA.

COMPLETED
Registry status
NA
Development phase
92 participants
Enrollment target

Study Summary

The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.

Primary Outcome

Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)

Interventions

  • DEVICE Prevena™ Incision Management System (PIMS)
  • DEVICE Standard-of-care Dressing

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2012-02
Est. Completion 2013-12
Phase NA
KCI USA

11 total trials

What the finished NCT01450631 record still lists

NCT01450631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Prevena™ Incision Management System (PIMS) is the first listed.

NCT01450631 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01450631 about?

NCT01450631 is a clinical study titled "The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions". The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.

What is the current status of trial NCT01450631?

This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2012-02. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01450631?

The interventions under investigation include: Prevena™ Incision Management System (PIMS) (DEVICE), Standard-of-care Dressing (DEVICE).

Who is sponsoring clinical trial NCT01450631?

This trial is sponsored by KCI USA, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01450631's enrollment target sits among peer trials

92 937th of 2000 higher than 1,062 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 NCT01450631, the US trial registry maintained by the National Library of Medicine. NCT01450631 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.