Surgical Site Infection Clinical Trial
Official title:
A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
Verified date | July 2022 |
Source | 3M |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: The Subject: 1. is a female aged = 18 years 2. is able to provide her own informed consent 3. will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days 4. will require a surgical incision able to be covered completely by the PIMS skin interface 5. has a BMI = 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery 6. is preoperatively assessed to undergo a procedure with a CDC Wound Classification of: 1. 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 - 2. 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 7. is willing and able to return for all scheduled and required study visits 8. is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site Exclusion Criteria: The Subject: 1. is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System) 2. has a systemic bacterial or fungal infection at the time of surgery 3. has a remote-site skin infection at the time of surgery 4. has a life expectancy of < 12 months 5. is preoperatively assessed to undergo a procedure with a CDC Wound Classification of: 1. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract - OR - 2. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera 6. 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 7. 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 8. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
3M |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:
Unanticipated local inflammatory response Prolonged drainage Fluid collection Dehiscence Surgical site infection (SSI) |
Post-op Day 42 (+/- 10 days) after Cesarean section surgery | |
Secondary | Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:
Antimicrobials for surgical site infection Surgical drainage of the incision Surgical incision packing Adjunctive negative pressure therapy Debridement Re-operation |
Post-op Day: 42 (+/- 10 days) after Cesarean section surgery |
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