Clinical trial NCT01450631: The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
Official title: A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Complications
Surgical Site Infection
Surgical Wound Infection
Keywords: surgical site infection
nosocomial infection
post-operative complication
surgical incision risk
surgical incision infection
negative pressure wound therapy
wound management
cesarean section surgery
wound dehiscence
wound infection
surgical closure
wound disruption
subcutaneous approximation
wound separation
seroma
hematoma
subcutaneous closure
obesity
cesarean
incision
massive obesity
obese
pregnancy
cesarean delivery
superobesity
wound complication
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
timeFrame: Post-op Day: 42 (+/- 10 days) after Cesarean section surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Robert Heine, MD
role: PRINCIPAL_INVESTIGATOR
References: