Clinical trial NCT02390401: Vacuum Assisted Closure for Cesarean Section
Official title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Surgical Wound Infection
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Southern New Hampshire Medical Center
First posted: 2015-03-17
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Post-operative wound infection
timeFrame: 6 weeks post-operative
Secondary outcomes:
measure: Rate of seroma
timeFrame: 6 weeks post-operative
measure: Rate of hematoma
timeFrame: 6 weeks post-operative
measure: Deep and superficial infection
timeFrame: 6 weeks post-operative
measure: Readmission for infection
timeFrame: 6 weeks post-operative
measure: Re-operation
timeFrame: 6 weeks post-operative
measure: Antibiotic treatment
timeFrame: 6 weeks post-operative
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Nashua
country: United States
facility: Women's Care of Nashua
state: New Hampshire
city: Nashua
country: United States
facility: Dartmouth-Hitchcock Nashua
state: New Hampshire
city: Nashua
country: United States
facility: Southern New Hampshire Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Zachary Spalding, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Kristina Wihbey, MD
role: STUDY_CHAIR
References:
citation: 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.