Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

Not Applicable

Completed

• Conditions: Gastrointestinal Injury; Complicated Diverticulitis
• Interventions: Device: "Veraflo" device, Dakin's solution

• Registration Number: NCT02127164
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-04-30
• Study Start: 2014-05
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Results First Submitted: 2023-05-22
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"Veraflo" device, Dakin's solution	"Veraflo" device, Dakin's solution	-

Primary Outcome Measures

Name	Time	Method
Rate of Surgical Site Infection	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Wong-Baker Faces Pain Rating Scale	1 week	The Wong-Baker Faces Pain Rating scale is used to grade pain related to the presence/manipulation of the device. The Wong-Baker scale range is from 0 (No Hurt) to 10 (Hurts Worst) with numbers increasing by 2 (0, 2, 4, 6, 8, 10) and associated face images showing increased pain and sadness. Higher scores indicate increased pain, a worse outcome.

Trial Locations

Locations (1)

University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States