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NCT01713452 · ClinicalTrials.gov registry record · NA

A Randomized Trial of Ostomy Closure Techniques

A NA study of Wound Infection, sponsored by University of Minnesota.

Completed
Registry status
NA
Development phase
125
Enrollment target
1
Study location

NCT01713452 is a NA study of Wound Infection that has completed, run by University of Minnesota. The registered enrollment target is 125 participants, below the 366-participant average among 10 other Wound Infection trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01713452, a NA study of Wound Infection, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
NA
Development phase
125 participants
Enrollment target
1
Study location

Study Summary

Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative classification. The ideal stoma site closure technique is still debated in the current literature. The aim of this study was to compare the rate of SSI following two different stoma closure techniques, primary closure versus a skin approximating purse string closure, in a multi-center randomized controlled trial. The investigators hypothesize that purse string closure technique will have a lower rate of SSI than primary closure technique.

Conditions Studied

Interventions

  • PROCEDURE Purse string closure
  • PROCEDURE Primary closure

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2008-12
Est. Completion 2012-10
Phase NA

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT01713452

The ClinicalTrials.gov registry entry for NCT01713452 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 366-participant average among 10 other Wound Infection trials with a reported enrollment target (66% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Wound Infection appearing as the primary indexed condition, and to 2 interventions - of which Purse string closure is the first listed.

NCT01713452 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT01713452 about?

NCT01713452 is a clinical study titled "A Randomized Trial of Ostomy Closure Techniques". Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative classification. The ideal stoma site closure technique is still debated in ...

What is the current status of trial NCT01713452?

This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2008-12. Estimated completion is 2012-10.

What conditions does trial NCT01713452 study?

This clinical trial studies the following conditions: Wound Infection.

What interventions are being tested in trial NCT01713452?

The interventions under investigation include: Purse string closure (PROCEDURE), Primary closure (PROCEDURE).

Who is sponsoring clinical trial NCT01713452?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01713452 being conducted?

This trial has 1 study location across Minnesota. 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 Editorial

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