Back to resultsVacuum Assisted Closure for Cesarean Section (VACCS)
Primary Purpose
Surgical Wound Infection
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vacuum-assisted closure
Standard sterile dressing
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
- Women's Care of Nashua
- Dartmouth-Hitchcock Nashua
- Southern New Hampshire Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vacuum-assisted closure (VAC)
Standard sterile dressing
Arm Description
Prevena (VAC) device
Standard sterile dressing
Outcomes
Primary Outcome Measures
Post-operative wound infection
Determine number of post-operative wound infections
Secondary Outcome Measures
Rate of seroma
Calculate incidence of seroma
Rate of hematoma
Calculate incidence of hematoma
Deep and superficial infection
Calculate incidence of deep and superficial infection
Readmission for infection
Calculate incidence of readmission to hospital for infection due to cesarean incision
Re-operation
Calculate incidence of re-operation to patients enrolled in study
Antibiotic treatment
Calculate incidence of need for antibiotic treatment for enrolled patients
Full Information
NCT ID
NCT02390401
First Posted
March 11, 2015
Last Updated
May 20, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Southern New Hampshire Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02390401
Brief Title
Vacuum Assisted Closure for Cesarean Section
Acronym
VACCS
Official Title
Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Continuation was futile per calculation recommend by data & safety monitoring committee
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Southern New Hampshire Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vacuum-assisted closure (VAC)
Arm Type
Experimental
Arm Description
Prevena (VAC) device
Arm Title
Standard sterile dressing
Arm Type
Active Comparator
Arm Description
Standard sterile dressing
Intervention Type
Device
Intervention Name(s)
Vacuum-assisted closure
Other Intervention Name(s)
Prevena, Incisional VAC
Intervention Description
Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
Intervention Type
Device
Intervention Name(s)
Standard sterile dressing
Intervention Description
Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.
Primary Outcome Measure Information:
Title
Post-operative wound infection
Description
Determine number of post-operative wound infections
Time Frame
6 weeks post-operative
Secondary Outcome Measure Information:
Title
Rate of seroma
Description
Calculate incidence of seroma
Time Frame
6 weeks post-operative
Title
Rate of hematoma
Description
Calculate incidence of hematoma
Time Frame
6 weeks post-operative
Title
Deep and superficial infection
Description
Calculate incidence of deep and superficial infection
Time Frame
6 weeks post-operative
Title
Readmission for infection
Description
Calculate incidence of readmission to hospital for infection due to cesarean incision
Time Frame
6 weeks post-operative
Title
Re-operation
Description
Calculate incidence of re-operation to patients enrolled in study
Time Frame
6 weeks post-operative
Title
Antibiotic treatment
Description
Calculate incidence of need for antibiotic treatment for enrolled patients
Time Frame
6 weeks post-operative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Spalding, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristina Wihbey, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Women's Care of Nashua
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060-3922
Country
United States
Facility Name
Dartmouth-Hitchcock Nashua
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Southern New Hampshire Medical Center
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29995726
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.
Results Reference
derived
Learn more about this trial
Vacuum Assisted Closure for Cesarean Section
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