Vacuum Assisted Closure for Cesarean Section

Surgical Wound Infection Clinical Trial

— VACCS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02390401
• Other study ID #: D15054
• Status: Terminated
• Phase: Phase 1
• Start date: May 2015
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Dartmouth-Hitchcock Nashua	Nashua	New Hampshire
United States	Southern New Hampshire Medical Center	Nashua	New Hampshire
United States	Women's Care of Nashua	Nashua	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Southern New Hampshire Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative wound infection	Determine number of post-operative wound infections	6 weeks post-operative
Secondary	Rate of seroma	Calculate incidence of seroma	6 weeks post-operative
Secondary	Rate of hematoma	Calculate incidence of hematoma	6 weeks post-operative
Secondary	Deep and superficial infection	Calculate incidence of deep and superficial infection	6 weeks post-operative
Secondary	Readmission for infection	Calculate incidence of readmission to hospital for infection due to cesarean incision	6 weeks post-operative
Secondary	Re-operation	Calculate incidence of re-operation to patients enrolled in study	6 weeks post-operative
Secondary	Antibiotic treatment	Calculate incidence of need for antibiotic treatment for enrolled patients	6 weeks post-operative