Vacuum Assisted Closure for Cesarean Section (VACCS)

Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese

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.

Study Overview

• Status: Terminated
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: Vacuum-assisted closure; Device: 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 Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
    • Nashua, New Hampshire, United States, 03060-3922
      • Women's Care of Nashua
    • Nashua, New Hampshire, United States, 03060
      • Dartmouth-Hitchcock Nashua
    • Nashua, New Hampshire, United States, 03060
      • Southern New Hampshire Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vacuum-assisted closure (VAC); Prevena (VAC) device	Device: Vacuum-assisted closure; Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.; Other Names: Prevena; Incisional VAC
ACTIVE_COMPARATOR: Standard sterile dressing	Device: Standard sterile dressing; Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative wound infection	Determine number of post-operative wound infections	6 weeks post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Southern New Hampshire Medical Center
• Investigators: Principal Investigator: Zachary Spalding, MD, Dartmouth-Hitchcock Medical Center; Study Chair: Kristina Wihbey, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• Wihbey KA, Joyce EM, Spalding ZT, Jones HJ, MacKenzie TA, Evans RH, Fung JL, Goldman MB, Erekson E. Prophylactic Negative Pressure Wound Therapy and Wound Complication After Cesarean Delivery in Women With Class II or III Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2018 Aug;132(2):377-384. doi: 10.1097/AOG.0000000000002744.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (ESTIMATE): March 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 20, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: D15054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes