Vacuum Assisted Closure for Cesarean Section (VACCS)

• ClinicalTrials.gov Identifier: NCT02390401
• Recruitment Status: Terminated
• First Posted: March 17, 2015
• Last Update Posted: May 22, 2018
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Southern New Hampshire Medical Center
• Information provided by (Responsible Party): Zachary Spalding, Dartmouth-Hitchcock Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgical Wound Infection	Device: Vacuum-assisted closure; Device: Standard sterile dressing	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: September 2017

Arms and Interventions

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; 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.

Outcome Measures

Primary Outcome Measures :

1. Post-operative wound infection [ Time Frame: 6 weeks post-operative ]
   Determine number of post-operative wound infections

Secondary Outcome Measures :

1. Rate of seroma [ Time Frame: 6 weeks post-operative ]
   Calculate incidence of seroma
2. Rate of hematoma [ Time Frame: 6 weeks post-operative ]
   Calculate incidence of hematoma
3. Deep and superficial infection [ Time Frame: 6 weeks post-operative ]
   Calculate incidence of deep and superficial infection
4. Readmission for infection [ Time Frame: 6 weeks post-operative ]
   Calculate incidence of readmission to hospital for infection due to cesarean incision
5. Re-operation [ Time Frame: 6 weeks post-operative ]
   Calculate incidence of re-operation to patients enrolled in study
6. Antibiotic treatment [ Time Frame: 6 weeks post-operative ]
   Calculate incidence of need for antibiotic treatment for enrolled patients

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Women's Care of Nashua

Nashua, New Hampshire, United States, 03060-3922

Dartmouth-Hitchcock Nashua

Nashua, New Hampshire, United States, 03060

Southern New Hampshire Medical Center

Nashua, New Hampshire, United States, 03060

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Southern New Hampshire Medical Center

Investigators

• Principal Investigator: Zachary Spalding, MD; Dartmouth-Hitchcock Medical Center
• Study Chair: Kristina Wihbey, MD; Dartmouth-Hitchcock Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Zachary Spalding, Physician-Resident, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT02390401
• Other Study ID Numbers: D15054
• First Posted: March 17, 2015
• Last Update Posted: May 22, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Wound Infection; Surgical Wound Infection; Surgical Wound; Infection; Wounds and Injuries; Postoperative Complications; Pathologic Processes