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Vacuum Assisted Closure for Cesarean Section (VACCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390401


Locations
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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
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Principal Investigator: Zachary Spalding, MD Dartmouth-Hitchcock Medical Center
Study Chair: Kristina Wihbey, MD Dartmouth-Hitchcock Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zachary Spalding, Physician-Resident, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02390401    
Other Study ID Numbers: D15054
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Surgical Wound
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes