Vacuum Assisted Closure for Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

NCT00654641

Surgical Wound Dehiscence Wound Infection

TERMINATED NA

A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery

NCT02534116

Abdominal Reconstruction

WITHDRAWN NA

The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity

NCT00696462

Cesarean Section

WITHDRAWN NA

Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients

NCT03082664

High Risk Pregnancy Cesarean Wound Disruption With Postnatal Complication

COMPLETED NA

Investigation of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection

NCT05856968

Pregnancy, Obesity

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vacuum-assisted closure (VAC)

Prevena (VAC) device

Group Type EXPERIMENTAL

Vacuum-assisted closure

Intervention Type DEVICE

Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.

Standard sterile dressing

Group Type ACTIVE_COMPARATOR

Standard sterile dressing

Intervention Type DEVICE

Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.