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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02892435

Enrollment

120

Registered

2016-09-08

Start date

2014-11-30

Completion date

2017-12-31

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICEincisional negative pressure wound therapy

positioning incisional negative pressure therapy over closed wound.

DEVICEconventional dressing

positioning conventional dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* abdominal surgery * open surgery * contaminated or dirty surgery

Exclusion criteria

* not abdominal surgery * mininvasive surgery * clean surgery

Design outcomes

Primary

Measure	Time frame	Description
Surgical Site Infection (SSI) reduction	7 months	quantify SSI decrease after incisional negative pressure wound therapy

Secondary

Measure	Time frame	Description
Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer	2 years	check connection between wound complications and risk factors and showing if Incisional Negative Pressure Wound Therapy (INPWT) could reduce effects of these risk factors

Countries

Italy

Contacts

Primary ContactAlessia Garzi, MD

alessia.garzi@gmail.com0574804612

Backup ContactMarco Scatizzi, MD

fferoci@usl4.toscana.it0574804612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026