NCT01450631

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

A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: KCI USA, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-operative Complications
• Surgical Site Infection
• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	Prevena™ Incision Management System (PIMS)	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.
DEVICE	Standard-of-care Dressing	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-10-12
• Last updated: 2024-10-16
• Results posted: 2014-08-01

Locations

1 site across 1 country: United States