The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions

Inclusion Criteria

The Subject:

• is a female aged ≥ 18 years
• is able to provide her own informed consent
• will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days
• will require a surgical incision able to be covered completely by the PIMS skin interface
• has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery
• is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
• 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 -
• 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
• is willing and able to return for all scheduled and required study visits
• is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site

Exclusion Criteria

The Subject:

• is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System)
• has a systemic bacterial or fungal infection at the time of surgery
• has a remote-site skin infection at the time of surgery
• has a life expectancy of < 12 months
• is preoperatively assessed to undergo a procedure with 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
• experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC) or other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration
• who, in the investigator's opinion, would have any clinically significant condition that would impair the participant's ability to comply with the study procedures
• has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives