A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27705 |
| Conditions: |
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Post-operative Complications - Surgical Site Infection - Surgical Wound Infection |
| Purpose: |
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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.
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| Study Summary: |
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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 compared to a control arm treated with a standard-of-care surgical incision
dressing. The prospective, post-marketing clinical study described in this protocol will
assess the effectiveness and functional performance of PIMS on closed incisions. Clinical
outcomes of interest for this study are defined as Surgical Site Occurrences (SSOs) that
include unanticipated local inflammatory response, prolonged drainage, fluid collection,
dehiscence, and surgical site infection (SSI). This investigation will compare these
outcomes to a control group consisting of Subjects screened for the same inclusion and
exclusion criteria but treated with a standard-of-care surgical incision dressing.
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| Criteria: |
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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 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
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| NCT ID: |
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NCT01450631 |
| Primary Contact: |
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Study Director
Brett Gilmore, JD, MSHS, BSN, RN
KCI USA, Inc.
Bonnie Thiele
Phone: 919-681-5220
Email: bonnie.thiele@dm.duke.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Durham, North Carolina 27705
United States
Robert Heine, MD
Phone: 919-681-5220
Email: robert.heine@dm.duke.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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