Prevena™ Incision Management System vs Conventional Management for Wound Healing

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892435
• Other study ID #: 012/2015
• Status: Recruiting
• Phase: Phase 2
• First received: May 19, 2015
• Last updated: September 1, 2016
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Ospedale Misericordia e Dolce
• Contact: Alessia Garzi, MD
• Phone: 0574804612
• Email: alessia.garzi[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• abdominal surgery

• open surgery

• contaminated or dirty surgery

Exclusion Criteria:

• not abdominal surgery

• mininvasive surgery

• clean surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contaminated Abdominal Surgery
• Dirty Abdominal Surgery
• Emergencies
• Emergency Abdominal Surgery
• Negative-Pressure Wound Therapy
• Prevena
• Wound Healing
• Wounds and Injuries

Intervention

Device:
• incisional negative pressure wound therapy
positioning incisional negative pressure therapy over closed wound.
• conventional dressing
positioning conventional dressing

Locations

Country	Name	City	State
Italy	Misericordia e Dolce Hospital	Prato	Po

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection (SSI) reduction	quantify SSI decrease after incisional negative pressure wound therapy	7 months	No
Secondary	Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer	check connection between wound complications and risk factors and showing if Incisional Negative Pressure Wound Therapy (INPWT) could reduce effects of these risk factors	2 years	No