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Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

Primary Purpose

Gastrointestinal Injury, Complicated Diverticulitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Veraflo" device, Dakin's solution
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arizona Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"Veraflo" device, Dakin's solution

Arm Description

Outcomes

Primary Outcome Measures

Rate of surgical site infection
Rate of surgical site infection and microbial colonization rate (which is directly related to the likelihood of delayed primary closure on postoperative day 4). Wound 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. Wounds can also be regarded as infected based on the individual discretion of the treating physician. Wounds with >10^5 colonization in swab will be considered contaminated

Secondary Outcome Measures

Time to complete wound closure
Pain score as defined by the Wong-Baker Pain Scale related to the presence/manipulation of the device

Full Information

First Posted
April 4, 2014
Last Updated
April 12, 2021
Sponsor
University of Arizona
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT02127164
Brief Title
Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries
Official Title
Prospective Evaluation of Wound Management Using Vacuum Assisted Instillation Therapy in Emergent Contaminated Abdominal Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Injury, Complicated Diverticulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Veraflo" device, Dakin's solution
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
"Veraflo" device, Dakin's solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of surgical site infection
Description
Rate of surgical site infection and microbial colonization rate (which is directly related to the likelihood of delayed primary closure on postoperative day 4). Wound 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. Wounds can also be regarded as infected based on the individual discretion of the treating physician. Wounds with >10^5 colonization in swab will be considered contaminated
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time to complete wound closure
Time Frame
Participants will be followed for an average of 4 weeks
Title
Pain score as defined by the Wong-Baker Pain Scale related to the presence/manipulation of the device
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Tang, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

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