Start Date: June 2014-2015
Enrolling: This clinical trial hopes to enroll 20 patients
Principal Investigator: Andrew L. Tang, MD, Assistant Professor of Surgery
Interests: Wound management, chest trauma, traumatic brain injury
Sponsor: Investigator initiated
ClinicalTrials.gov: More Information
Research Coordinator: Laurel Rokowski, RN Laurel@surgery.arizona.edu
Banner - UMC Tucson to Conduct Clinical Trial to Reduce Surgical Infections
The Banner – University Medical Center Tucson is conducting a clinical trial to compare which of the current treatments for surgical wounds are most effective in preventing surgical site infections (SSI) after emergency abdominal surgery.
The skin is a natural barrier against infection. Surgical incisions cause breaks in this natural barrier and predispose patients to infections. Surgical site infections (SSIs) are the third most common hospital-acquired infections, accounting for 15 percent of all such infections.
Emergency abdominal surgeries have a very high rate of wound contamination and risk of infection due to exposure to bacteria from the gastrointestinal tract. Current, commonly accepted treatments for contaminated surgical wounds to prevent an SSI include leaving the wound open and dressing it with wet-to-dry gauze or the use of a vacuum-assisted device (VAC).
A relatively new technology in wound management is the V.A.C. Ulta™ Negative Pressure Wound Therapy System, a 510(k) –cleared, Class II device (K100657). A special foam dressing with an attached tube is placed inside the wound and tightly covered. The tube is connected to a pump which helps suck out excess fluid from the wound. Dakin’s solution, an antimicrobial solution, also is infused into the wound to decontaminate it. The combined action of the antimicrobial solution and the application of constant negative pressure therapy to a wound through a porous sponge stimulate local blood flow and removes harmful enzymes to promote healing.
Although vacuum-assisted closure has revolutionized the management of complicated wounds over the last 15 years, the immediate application of the VAC device with Dakin’s infusion immediately after emergent, highly contaminated operations has not been studied.
This investigator-initiated clinical trial, led by Andrew Tang, MD, assistant professor, UA Department of Surgery Division of Trauma, Critical Care, Burns and Emergency Surgery, will examine whether using the VAC device with Dakin’s Quarter Strength® 0.125% in patients undergoing emergency surgery will achieve earlier wound closure, decrease patient discomfort, improve cost savings and potentially standardize and revolutionize the management of heavily contaminated wounds.
“We expect the use of the vacuum-assisted device for wound care will decrease chances of wound infection, decrease pain associated with the wound, and decrease time for wound care,” said Dr. Tang.
The study will enroll approximately 20 patients. The device will be used as long as four days after surgery. Informed consent will be obtained from non-trauma emergency general surgical patients.
For more information about the trial please contact Laurel Rokowski, RN, research coordinator, at 520-626-2876 or Laurel@surgery.arizona.edu.
View the V.A.C. Ulta Application video
Information regardiing Dakin’s Quarter Strength ® (0.125%)