PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Cesarean Section Complications, Cesarean Wound; Dehiscence, Cesarean Wound Disruption
About this trial
This is an interventional prevention trial for Cesarean Section Complications focused on measuring cesarean section, negative-pressure wound therapy, surgical wound dehiscence, hospital readmission, surgical site infection
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Long Island Jewish Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PICO Dressing
Standard Dressing
PICO Negative Pressure Wound Therapy (Smith and Nephew Healthcare, Hull, United Kingdom) is a non-significant-risk, FDA Class II, medical device commercially available in the USA. The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.
The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing.