Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

Study Overview
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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.

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

Conditions
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Complicated Diverticulitis, Gastrointestinal Injury

Intervention / Treatment
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* Device: Veraflo device, Dakin's solution


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Veraflo device, Dakin's solution<br> | Device: Veraflo device, Dakin's solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete wound closure |  | Participants will be followed for an average of 4 weeks | 
| Pain score as defined by the Wong-Baker Pain Scale related to the presence/manipulation of the device |  | 1 week |