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NCT02127164 · ClinicalTrials.gov registry record · NA

Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

A NA study of Gastrointestinal Injury and Complicated Diverticulitis, sponsored by University of Arizona.

Completed
Registry status
NA
Development phase
18
Enrollment target
1
Study location

NCT02127164: Completed NA study of Gastrointestinal Injury and Complicated Diverticulitis, sponsored by University of Arizona.

NCT02127164 is a NA study of Gastrointestinal Injury and Complicated Diverticulitis that has completed, run by University of Arizona. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02127164, a NA study of Gastrointestinal Injury and Complicated Diverticulitis, has completed, sponsored by University of Arizona.

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

Study Summary

Emergent abdominal surgeries have very high rate of wound contamination due to exposure to bacteria from GI tract. There are several different approaches to wound management in these patients including wet-to-dry dressing or application vacuum assisted device on the wound. The investigators propose using the vacuum assisted device with Dakin's solution on patients undergoing emergency surgery for hollow viscus perforation installed immediately at the end of operation and remained there for the first 3 postoperative days, followed by delayed primary closure on postoperative day 4. The investigators believe this technique can achieve earlier wound closure, decrease patient discomfort, improve cost savings, and potentially standardize and revolutionize the investigators management of heavily contaminated wounds.

Primary Outcome

Surgical site infection is defined as the presence of localized inflammatory signs such as hyperthermia, erythema, tenderness, or purulent discharge that results in positive cultures, along with positive wound cultures. Surgical site can also be regarded as infected based on the individual discretion of the treating physician. Surgical sites with \>10\^5 colonization in swab will be considered contaminated.

Interventions

  • DEVICE "Veraflo" device, Dakin's solution

Study Locations (1)

Arizona

  • University of Arizona Medical Center - Tucson

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2014-05
Est. Completion 2017-06
Phase NA
University of Arizona

349 total trials

What the finished NCT02127164 record still lists

NCT02127164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Gastrointestinal Injury appearing as the primary indexed condition, and to 1 intervention - of which "Veraflo" device, Dakin's solution is the first listed.

NCT02127164 reports a single indexed study location in Arizona.

Frequently Asked Questions

What is clinical trial NCT02127164 about?

NCT02127164 is a clinical study titled "Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries". Emergent abdominal surgeries have very high rate of wound contamination due to exposure to bacteria from GI tract. There are several different approaches to wound management in these patients including wet-to-dry dressing or application vacuum assisted device on the wound. The investigators propose ...

What is the current status of trial NCT02127164?

This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2014-05. Estimated completion is 2017-06.

What conditions does trial NCT02127164 study?

This clinical trial studies the following conditions: Gastrointestinal Injury, Complicated Diverticulitis.

What interventions are being tested in trial NCT02127164?

The interventions under investigation include: "Veraflo" device, Dakin's solution (DEVICE).

Who is sponsoring clinical trial NCT02127164?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02127164 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02127164's enrollment target sits among peer trials

18 1863rd of 2000 higher than 130 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 NCT02127164, the US trial registry maintained by the National Library of Medicine. NCT02127164 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.