Status:
COMPLETED
PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Lead Sponsor:
Northwell Health
Conditions:
Cesarean Section Complications
Cesarean Wound; Dehiscence
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3 interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing elective cesarean...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study; willing and able to return for all scheduled and required study visits
- Female, aged 18 - 55 years
- BMI ≥ 35 kg/m2 in the 42 days prior to surgery
- In good general health as evidenced by medical history with a 24 - 41 weeks gestational age pregnancy scheduled for cesarean delivery for any routine indication (repeat procedure, breech presentation, abnormal placentation, uterine anomaly, maternal medical condition, or elective)
- Surgical skin site preparation with chlorhexidine gluconate solution (ChloraPrep©)
- Received preoperative surgical prophylaxis antibiotics as per protocol
- Surgical incision that can be covered completely by the NPWT skin system
- Pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
- a. Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered
- OR - b. Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination
- Wound hemostasis has been achieved
Exclusion
- Cesarean delivery before fetal viability (24 0/7 weeks gestational age)
- Unplanned Cesarean delivery
- Intrauterine fetal demise
- Known allergic reactions to components of the PICO NPWT system
- Systemic bacterial or fungal infection at the time of surgery
- Diagnosis of systemic or remote-site skin infections at time of delivery
- Treatment with another investigational drug or other intervention within 7 days prior to cesarean delivery or 42 +/- 10 days after cesarean delivery
- Delivery for suspected intrauterine infection (defined as maternal fever plus one clinical criteria)
- Critical illness or immune-compromising disease (eg acquired immunodeficiency syndrome)
- Chronic steroid use
- Pre-operatively assessed to have a CDC Wound Classification of:
- Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
- OR - Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- High-risk for anesthesia (American Society of Anesthesiologists \[ASA\] class P4 - P6)
- Intra-operative hemorrhage requiring blood transfusion, disseminated-intravascular coagulopathy (DIC) or any other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration
- Unable to speak or understand English, with no interpreter available.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03414762
Start Date
April 1 2019
End Date
September 30 2022
Last Update
February 29 2024
Active Locations (1)
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1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040