Prevena™ Incision Management System vs Conventional Management for Wound Healing

NCT ID: NCT02892435

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prevena arm

patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days

Group Type EXPERIMENTAL

incisional negative pressure wound therapy

Intervention Type DEVICE

positioning incisional negative pressure therapy over closed wound.

Control arm

patients underwent to contaminated/dirty surgery who positioned conventional dressing

Group Type ACTIVE_COMPARATOR

conventional dressing

Intervention Type DEVICE

positioning conventional dressing

Interventions

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incisional negative pressure wound therapy

positioning incisional negative pressure therapy over closed wound.

Intervention Type DEVICE

conventional dressing

positioning conventional dressing

Intervention Type DEVICE

Other Intervention Names

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Prevena - KCI

Eligibility Criteria

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Inclusion Criteria

* abdominal surgery
* open surgery
* contaminated or dirty surgery

Exclusion Criteria

* not abdominal surgery
* mininvasive surgery
* clean surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Misericordia e Dolce

OTHER

Sponsor Role lead

Responsible Party

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Marco Scatizzi

Chief, general surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Feroci, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Santo Stefano Prato

Locations

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Misericordia e Dolce Hospital

Prato, Po, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessia Garzi, MD

Role: CONTACT

0574804612 ext. +39

Marco Scatizzi, MD

Role: CONTACT

0574804612 ext. +39

Facility Contacts

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Francesco Feroci, MD

Role: primary

+393398382381

Other Identifiers

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012/2015

Identifier Type: -

Identifier Source: org_study_id

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