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

NCT01450631 | Completed Results

• 1 other identifier: AHS.2011.Prevena.Heine.03
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Standard Dressing

ACTIVE COMPARATOR

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.

Device: Standard-of-care Dressing

Prevena™ (PIMS)

EXPERIMENTAL

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.

Device: Prevena™ Incision Management System (PIMS)

Interventions

Prevena™ Incision Management System (PIMS) DEVICE

PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The 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. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.

Also known as: PIMS, NPWT, Negative Pressure Wound Therapy

Prevena™ (PIMS)

Standard-of-care Dressing DEVICE

The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.

Also known as: Standard Dressing

Standard Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection; Wound Infection; Seroma; Hematoma; Obesity; Surgical Wound

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes; Inflammation; Hemorrhage; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Jill Twardowski, Director of Clinical Operations
• Organization: KCI USA, Inc.

jill.twardowski@kci1.com

210-515-4166

Study Officials

• Robert Heine, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 12, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 16, 2024
• Results First Posted: August 1, 2014

Record last verified: 2024-10

Locations

US (1)