Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

NCT02127164 | Completed Results

• 1 other identifier: UAKCI2014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Injury; Complicated Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Rate of Surgical Site Infection

  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.

  2 weeks

Secondary Outcomes (1)

• Wong-Baker Faces Pain Rating Scale

  1 week

Study Arms (1)

"Veraflo" device, Dakin's solution

EXPERIMENTAL

Device: "Veraflo" device, Dakin's solution

Interventions

"Veraflo" device, Dakin's solution 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.

"Veraflo" device, Dakin's solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prisoners
• Pregnancy
• Patients with allergy to Dakin's (sodium hypochlorite) solution.

Sponsors & Collaborators

• University of Arizona: lead
• 3M: collaborator

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Limitations and Caveats

Limited sample size as a result of difficulty in consenting subjects prior to trauma surgery.

Results Point of Contact

• Title: Andrew Tang, MD
• Organization: University of Arizona

traumaresearch@arizona.edu

520-626-5056

Study Officials

• Andrew M Tang, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (1)