NCT02892435

Prevena™ Incision Management System vs Conventional Management for Wound Healing

Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ospedale Misericordia e Dolce · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

Detailed description

All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing. In the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score. Moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.

Conditions

• Wound Healing
• Prevena
• Dirty Abdominal Surgery
• Contaminated Abdominal Surgery
• Emergency Abdominal Surgery
• Negative-Pressure Wound Therapy

Interventions

Type	Name	Description
DEVICE	incisional negative pressure wound therapy	positioning incisional negative pressure therapy over closed wound.
DEVICE	conventional dressing	positioning conventional dressing

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2016-09-08
• Last updated: 2016-09-08

Locations

1 site across 1 country: Italy