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OpenTrials
Completed

NCT Number: NCT02127164

Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

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.

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Key information

Conditions

Gastrointestinal Injury Complicated Diverticulitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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.

Primary outcomes

  1. Rate of Surgical Site Infection

    Time frame: 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 outcomes

  1. Wong-Baker Faces Pain Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2014
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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