Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery

Not Applicable

Terminated

Conditions: Obesity
Surgical Site Infections
Complications; Cesarean Section
Wound Complications

Interventions: Device: Negative Pressure Wound Therapy Dressing
Device: Standard Dressing

Registration Number: NCT02799667

Lead Sponsor: Tufts Medical Center

Brief Summary: The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.

Detailed Description: Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI \> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 110

Inclusion Criteria

BMI >40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.

Exclusion Criteria

Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI < 40 kg/m2 will be excluded from this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy Dressing	Negative Pressure Wound Therapy Dressing	Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.
Standard Dressing	Standard Dressing	Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment	2 weeks post partum/post operative period	Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment	2 weeks post partum/post operative period	Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively	6 weeks post partum/post operative period	Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment	2 weeks post partum/post operative period	The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively	6 weeks post partum/post operative period	The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.	6 weeks post partum/post operative period	Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.