PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.

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 Read More

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.