Study Stopped
Continuation was futile per calculation recommend by data \& safety monitoring committee
Vacuum Assisted Closure for Cesarean Section
VACCS
Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
1 other identifier
interventional
166
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2015
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMay 22, 2018
May 1, 2018
2.2 years
March 11, 2015
May 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative wound infection
Determine number of post-operative wound infections
6 weeks post-operative
Secondary Outcomes (6)
Rate of seroma
6 weeks post-operative
Rate of hematoma
6 weeks post-operative
Deep and superficial infection
6 weeks post-operative
Readmission for infection
6 weeks post-operative
Re-operation
6 weeks post-operative
- +1 more secondary outcomes
Study Arms (2)
Vacuum-assisted closure (VAC)
EXPERIMENTALPrevena (VAC) device
Standard sterile dressing
ACTIVE COMPARATORStandard sterile dressing
Interventions
Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Women's Care of Nashua
Nashua, New Hampshire, 03060-3922, United States
Dartmouth-Hitchcock Nashua
Nashua, New Hampshire, 03060, United States
Southern New Hampshire Medical Center
Nashua, New Hampshire, 03060, United States
Related Publications (1)
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.
PMID: 29995726DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zachary Spalding, MD
Dartmouth-Hitchcock Medical Center
- STUDY CHAIR
Kristina Wihbey, MD
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician-Resident
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 17, 2015
Study Start
May 1, 2015
Primary Completion
July 1, 2017
Study Completion
September 1, 2017
Last Updated
May 22, 2018
Record last verified: 2018-05