The Use of the Prevenaâ„¢ Incision Management System on Post-Surgical Cesarean Section Incisions (NCT01450631) | Clinical Trial Compass
CompletedNot Applicable
The Use of the Prevenaâ„¢ Incision Management System on Post-Surgical Cesarean Section Incisions
United States92 participantsStarted 2012-02
Plain-language summary
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevenaâ„¢ Incision Management System in women undergoing Cesarean section surgery.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Timeframe: Post-op Day 42 (+/- 10 days) after Cesarean section surgery
✕. 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
✕. 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