The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions

Not Applicable

Completed

• Conditions: Post-operative Complications; Surgical Wound Infection; Surgical Site Infection
• Interventions: Device: Standard-of-care Dressing; Device: Prevena™ Incision Management System (PIMS)

• Registration Number: NCT01450631
• Lead Sponsor: KCI USA, Inc

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.

Study Timeline

• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Study Start: 2012-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-07-03
• Results First Submitted QC: 2014-07-03
• Results First Posted: 2014-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dressing	Standard-of-care Dressing	Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Prevena™ (PIMS)	Prevena™ Incision Management System (PIMS)	PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.	Post-op Day 42 (+/- 10 days) after 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)

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.	Post-op Day: 42 (+/- 10 days) after 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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States