Clinical trial NCT02289157: Negative Pressure Wound Therapy in Cesarean Section
Official title: Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Wound Complications
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2014-11-13
Enrollment: 441
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Placebo Controlled Clinical Trial - Open Label
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with BMI \> 40 undergoing a cesarean delivery at Parkland Health and Hospital System.

Exclusion Criteria:

* Any patient not meeting inclusion criteria will be deemed ineligible.
* All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
* Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
* according to the wound therapy manufacturer's instructions patients with:

  * fragile skin
  * allergy to silver or acrylic adhesives
  * a malignancy in the wound bed or margins of the wound bed
  * non-enteric and unexplored fistulas
  * necrotic tissue with eschar present
  * exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.

Primary outcomes:
measure: Number of Participants With Wound Complication
timeFrame: Day of surgery to 30 days postoperative
measure: Number of Participants With Classification of Wound Morbidity
timeFrame: Day of Surgery to 30 days postoperative
Secondary outcomes:
measure: Length of Postoperative Stay
timeFrame: Length of Postoperative Stay
measure: Length of Stay After Readmission
timeFrame: After dismissal and readmitted within 30 days for wound morbidity
measure: Number of Patients With Emergency Room Visits After Discharge
timeFrame: Day of surgery to 30 days postoperative
measure: Number of Patients With Number of Clinic Visits
timeFrame: Day of surgery to 30 days postoperative
measure: Number of Participants With Morbid Outcomes After Delivery
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Participants With Scheduled and Unscheduled Cesarean Section
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Patients in Labor Versus no Labor Prior to Cesarean Section
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Patients With Hypertension Versus no Hypertension
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes
timeFrame: Day of Surgery to 30 days postoperative
measure: Number of Patients With Chorioamnionitis Versus no Chorioamnionitis
timeFrame: Day of Surgery to 30 days postoperative
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Scott Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hussamy DJ, Wortman AC, McIntire DD, Leveno KJ, Casey BM, Roberts SW. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4):781-789. doi: 10.1097/AOG.0000000000003465.