NCT04214236 - CiNPT for Abdominoplasties in Post-bariatric Patients Study | Biotech Hunter

Enrollment

130

Participants

Timeline

Start Date

February 1, 2020

Primary Completion Date

November 1, 2022

Study Completion Date

January 31, 2023

Conditions

Obesity, MorbidObesityObesity, AbdominalWoundWound InfectionWound ComplicationWound DehiscenceWound ContaminationWound HealWound; AbdomenIncisionIncision Site RashIncision Site BleedingIncision Site SwellingIncision Site HaematomaIncision Site InfectionIncision Site InflammationIncision Site ComplicationIncision SurgicalSurgery--ComplicationsSurgical Wound InfectionSurgical Site InfectionScarring as Surgical ComplicationScarScarring

Interventions

DEVICE

ciNPT group

Closed-incision negative pressure therapy (ciNPT) will be applied for 7 day using continuous suction at 125 mmHg. To deliver ciNPT we will use a commercially available, FDA-approved device, used according to the manufacturer' indications (PREVENA™ Incision Management System (KCI, San Antonio, Texas, USA). After the first 7 post-operative days, subjects will discontinue the ciNPT and follow a standard wound care protocol.

OTHER

Control group

Standard non-adherent surgical dressing (Vaseline petrolatum gauze) will be used for management of incisional wounds in the control group. Dressing changes will be performed per standard wound care protocol.