PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.

PHASE3CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Cesarean Section ComplicationsCesarean Wound; DehiscenceCesarean Wound Disruption
Interventions
DEVICE

PICO Negative Pressure Wound Therapy

The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.The dressing is applied to the wound and extra strips are placed over the outside edge to help hold the dressing in place. When the pump is turned on, air is pulled out of the dressing and excess fluid from the wound will start to enter the dressing.

DEVICE

Standard 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

Trial Locations (1)

11040

Long Island Jewish Medical Center, New Hyde Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER

NCT03414762 - PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery. | Biotech Hunter | Biotech Hunter