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Vacuum Assisted Closure for Cesarean Section (VACCS)

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ClinicalTrials.gov Identifier: NCT02390401
Recruitment Status : Terminated (Continuation was futile per calculation recommend by data & safety monitoring committee)
First Posted : March 17, 2015
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Southern New Hampshire Medical Center
Information provided by (Responsible Party):
Zachary Spalding, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE March 11, 2015
First Posted Date  ICMJE March 17, 2015
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
Post-operative wound infection [ Time Frame: 6 weeks post-operative ]
Determine number of post-operative wound infections
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • Rate of seroma [ Time Frame: 6 weeks post-operative ]
    Calculate incidence of seroma
  • Rate of hematoma [ Time Frame: 6 weeks post-operative ]
    Calculate incidence of hematoma
  • Deep and superficial infection [ Time Frame: 6 weeks post-operative ]
    Calculate incidence of deep and superficial infection
  • Readmission for infection [ Time Frame: 6 weeks post-operative ]
    Calculate incidence of readmission to hospital for infection due to cesarean incision
  • Re-operation [ Time Frame: 6 weeks post-operative ]
    Calculate incidence of re-operation to patients enrolled in study
  • Antibiotic treatment [ Time Frame: 6 weeks post-operative ]
    Calculate incidence of need for antibiotic treatment for enrolled patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vacuum Assisted Closure for Cesarean Section
Official Title  ICMJE Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Surgical Wound Infection
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Vacuum-assisted closure (VAC)
    Prevena (VAC) device
    Intervention: Device: Vacuum-assisted closure
  • Active Comparator: Standard sterile dressing
    Standard sterile dressing
    Intervention: Device: Standard sterile dressing
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 20, 2018)
166
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2015)
400
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02390401
Other Study ID Numbers  ICMJE D15054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zachary Spalding, Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Southern New Hampshire Medical Center
Investigators  ICMJE
Principal Investigator: Zachary Spalding, MD Dartmouth-Hitchcock Medical Center
Study Chair: Kristina Wihbey, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP