Status:
COMPLETED
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
Lead Sponsor:
KCI USA, Inc
Conditions:
Post-operative Complications
Surgical Site Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
Detailed Description
This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevena™ Incision Management System (PIMS) on Cesarean section Subjects compare...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01450631
Start Date
February 1 2012
End Date
December 1 2013
Last Update
October 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27705