Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
Condition: High Risk Abdominal Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in
      high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).

      Hypothesis:

      Historically, the average rates of infective complications in surgical wounds types are 7.7%
      in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena
      ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce
      these rates by 50%.
    

Detailed description: 
      Wound infections continue to be a common and costly problem after surgery. Surgical site
      infections (SSIs) are the second most common type of health care - associated infections
      (HAI), occurring in 2% to 5% of patients undergoing surgery in the United States. This
      percentage corresponds to approximately 300,000 to 500,000 surgical site infections (SSIs)
      estimated to occur each year.

      Most SSIs that do not involve implants are diagnosed within 3 weeks post--operatively . SSIs
      lead to increased hospital stay, cost, and risk of death. The cost attributable to SSI range
      from $3,000 to $29,000 per SSI per patient depending on the type of operation; thus, the
      total annual cost approximately reaches the $10 billions. On other analyses documented nearly
      1 million additional inpatient-days and $1.6 billion in excess costs , as well as up to twice
      the costs of a patient without SSI. Moreover, SSIs increase mortality risk by 2 to 11 fold
      11, while the 77% of deaths in patients with SSI are attributed directly to the SSIs. Several
      organizations have put forth guidelines for definition and recommendations to decrease their
      incidence. Attempts have been made to stratify patients into various categories on the basis
      of the type of surgical procedure and risk factors the patients have, including diabetes,
      malnutrition, and hypoxemia. These systems have been used to develop criteria for the
      prevention of wound infection.

      Appropriate timing and dosing of antibiotics, type of skin preparation, temperature of the
      patient in the operating room, blood oxygen level of the patient during surgery, and
      management of blood glucose levels all have been standardized in an attempt to decrease wound
      infection rates . In addition, debridement of all tissue that may contribute to wound
      infection, particularly ischemic skin and subcutaneous tissue, is standard surgical
      procedure. Standardization has led to a small decrease in incidence but has not led to a
      significant reduction in the overall rate. One reason for this is the multifactorial nature
      of SSI development. Factors regarding patients and pre-operative status, operative procedures
      and intra-operative events, as well as postoperative course, all need to be addressed, and
      there is not a complete understanding of their range and impact. What is known is that at the
      time of wound closure, one needs a minimal number of bacteria in the wound, and the wound
      itself must be reasonably well perfused and oxygenated. After surgery, wound perfusion and
      oxygenation are evaluated by clinical appearance. If the wound does not appear ischemic, it
      is assumed that perfusion and oxygenation are adequate. Unfortunately, this has never been
      quantified. Negative-pressure wound therapy (NPWT) has been used to speed the healing of open
      wounds.

      How this occurs is not completely understood, but increased generation of granulation tissue
      at the margins of the open wound implies increased generation of blood vessels and substances
      needed to promote wound healing.

      The theory of negative pressure is the stimulation of wound healing on the basis of improved
      perfusion to the wound. This has been seen in open wounds and has recently been applied to
      closed surgical wounds thought to be at high risk for infection. Negative-pressure wound
      therapy was also applied to closed wounds in an attempt to improve wound perfusion and
      oxygenation, which in theory would eliminate these two variables from the wound infection
      equation.

      Techniques - Procedures Complete closure of the abdominal wall and skin follows the
      completion of the index surgical procedure. Closed suction drains may be used at the time of
      skin closure in any patient who requires skin flap elevation to attain skin closure. Skin
      closure will be accomplished with dermal sutures and / or staples. Wound coverage will be
      done with the NPWT Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio,
      TX). The application of the NPWT will be done as per manufacturer's instructions of use. The
      application of continuous negative pressure will be applied at 125 mm Hg.Antibiotics will be
      given to all patients. The post-operative use of antibiotics in the clear contaminated and
      contaminated cases will be 24-hour of prophylactic administration. The post-operative use of
      antibiotics for the dirty (infected) cases will be of therapeutic administration, as
      clinically indicated. In infected patients, cultures will be taken at the time of the index
      procedure, and the antibiotic treatment will be targeted to the culture results. Wounds will
      be assessed every 48 hours by dressing changes, and also at the time of final dressing
      removal and at 2 and 4 weeks after surgery. The dressing removal will take place at discharge
      OR at 5 - 7 post-operative days OR if clinically indicated, whichever comes first.
      Post-discharge follow-up The patients will be followed-up per routine at the surgical clinic.
      At 2 and 4 weeks after the date of the operation a formal evaluation will take place. Both
      evaluations must be in person at the surgical clinic.
    

Intervention name(s): Negative Pressure treatment
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prevena; faster healing time; surgical site infection