Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

NCT ID: NCT02127164

Last Updated: 2024-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Injury Complicated Diverticulitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"Veraflo" device, Dakin's solution

Group Type EXPERIMENTAL

"Veraflo" device, Dakin's solution

Intervention Type DEVICE

Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.

Interventions

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"Veraflo" device, Dakin's solution

Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Emergent surgery involving hollow viscus perforation or necrotic bowel
* Admitted to the University of Arizona Medical Center, Tucson, AZ

Exclusion Criteria

* Prisoners
* Pregnancy
* Patients with allergy to Dakin's (sodium hypochlorite) solution.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Andrew Tang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew M Tang, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UAKCI2014

Identifier Type: -

Identifier Source: org_study_id

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