Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

Gastrointestinal Injury Clinical Trial

Official title:

Prospective Evaluation of Wound Management Using Vacuum Assisted Instillation Therapy in Emergent Contaminated Abdominal Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127164
• Other study ID #: UAKCI2014
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 2017

Study information

• Verified date: January 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complicated Diverticulitis
• Diverticulitis
• Gastrointestinal Injury

Intervention

Device:
• "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.

Locations

Country	Name	City	State
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wong-Baker Faces Pain Rating Scale	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.	1 week