Vacuum Assisted Closure for Cesarean Section

Phase 1

Terminated

• Conditions: Surgical Wound Infection
• Interventions: Device: Standard sterile dressing; Device: Vacuum-assisted closure

• Registration Number: NCT02390401
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

Detailed Description

The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed "Incisional VAC") has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Study Start: 2015-05
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-20
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

• Patients that have undergone cesarean section for delivery; have a BMI greater or equal to 35. All cases of cesarean section including primary and repeat, scheduled and urgent.

Exclusion Criteria

• Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard sterile dressing	Standard sterile dressing	Standard sterile dressing
Vacuum-assisted closure (VAC)	Vacuum-assisted closure	Prevena (VAC) device

Primary Outcome Measures

Name	Time	Method
Post-operative wound infection	6 weeks post-operative	Determine number of post-operative wound infections

Secondary Outcome Measures

Name	Time	Method
Readmission for infection	6 weeks post-operative	Calculate incidence of readmission to hospital for infection due to cesarean incision
Rate of hematoma	6 weeks post-operative	Calculate incidence of hematoma
Rate of seroma	6 weeks post-operative	Calculate incidence of seroma
Re-operation	6 weeks post-operative	Calculate incidence of re-operation to patients enrolled in study
Antibiotic treatment	6 weeks post-operative	Calculate incidence of need for antibiotic treatment for enrolled patients
Deep and superficial infection	6 weeks post-operative	Calculate incidence of deep and superficial infection

Trial Locations

Locations (4)

Women's Care of Nashua; 🇺🇸 Nashua, New Hampshire, United States

Dartmouth-Hitchcock Nashua; 🇺🇸 Nashua, New Hampshire, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Southern New Hampshire Medical Center; 🇺🇸 Nashua, New Hampshire, United States