Negative Pressure Wound Therapy in Cesarean Section
Condition: Postoperative Wound Complications
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators propose a prospective, randomized trial evaluating the use of negative
      pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators
      hypothesize that negative pressure wound therapy will decrease the wound complications in
      these patients. The investigators aim to look at all wound complications such as infection
      and disruption and will be using Prevena incision management system for our NPWT device .
    

Detailed description: 
      This will be a prospective, randomized, controlled trial of pregnant women who present for
      prenatal care at Parkland Health and Hospital System. The participants will be limited to
      women undergoing a cesarean section who are high risk for wound complications: all patients
      with a BMI > 40 undergoing cesarean section.

      The primary outcome will be wound complication defined as wound disruption or wound
      infection. A wound disruption will be defined as the partial or complete opening of the deep
      subcutaneous space, not to include superficial skin separation. Underlying causes will
      include seroma, hematoma, abscess, and facial dehiscence. Wound infection will be defined as
      a physician diagnosis of wound infection with erythema and warmth extending beyond the
      immediate area adjacent to the incision and requiring treatment with antibiotics.

      All patients with a BMI > 40 undergoing scheduled cesarean section and patients with a BMI
      >40 who are admitted in labor will be approached to participate in the study. If patients
      meeting this criteria undergo cesarean section, they will be randomized to negative pressure
      wound therapy or a standard dressing. All labor treatment, pre-operative antibiotics,
      surgical technique, and post-operative care will not differ from current standard of care.
      All patients randomized will be included in the study.

      All study participants will have the thickness of their subcutaneous tissue measured with a
      sterile ruler. Patients randomized to NPWT will have a negative pressure wound therapy system
      placed over her incision per the manufacturer's protocol. All patients randomized to standard
      dressing will have the customary dressing of gauze and surgical tape placed over her
      incision.

      The investigators will be utilizing a single use negative pressure wound therapy system for
      the study. Single use negative pressure wound therapy systems are composed of a pressure pump
      and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the
      dressing directly covers surgical incision. The system is battery-powered and designed to be
      used for a minimum of two days and a maximum of seven days of continuous use.

      All randomized patients will undergo an examination of their incision by a research physician
      or nurse prior to discharge. The NPWT will be removed prior to discharge or on post-operative
      day seven, whichever comes first. All postpartum patients who undergo a cesarean delivery are
      inpatients until at least post-operative day three and will continue use of NPWT until day of
      discharge. In patients randomized to a standard dressing, the dressing will be removed prior
      to discharge per current standard of care.

      All randomized patients will also undergo a 2 week post-operative incisional examination by a
      research physician or nurse at the obstetrical complications clinic. Patients will be
      followed until 30 days postpartum for any wound complications to include wound infection
      (superficial and deep), readmission to the hospital, re-operation for wound complications,
      hematoma, seroma, dehiscence, superficial infection requiring antibiotics, or additional
      clinical evaluations for wound care in the emergency room or clinic setting. A research
      physician or nurse will contact each after at least 30 days post-operative to confirm the
      patients' status and ensure no evaluations, admissions, or interventions were done at outside
      facilities.

      Subjects will exit the study if they are unable to complete the post-operative visit or
      withdrawal consent for participation.
    

Intervention name(s): Negative pressure wound therapy
Intervention type(s): Device
Intervention description(s): Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
Other intervention name(s): Prevena
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Placebo Controlled Clinical Trial - Open Label
Masking: None (Open Label)
Primary purpose: Treatment