Prevena™ Incision Management System vs Conventional Management for Wound Healing
NCT ID: NCT02892435
Last Updated: 2016-09-08
Study Results
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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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2014-11-30
2017-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
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
incisional negative pressure wound therapy
positioning incisional negative pressure therapy over closed wound.
Control arm
patients underwent to contaminated/dirty surgery who positioned conventional dressing
conventional dressing
positioning conventional dressing
Interventions
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incisional negative pressure wound therapy
positioning incisional negative pressure therapy over closed wound.
conventional dressing
positioning conventional dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* open surgery
* contaminated or dirty surgery
Exclusion Criteria
* mininvasive surgery
* clean surgery
18 Years
90 Years
ALL
No
Sponsors
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Ospedale Misericordia e Dolce
OTHER
Responsible Party
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Marco Scatizzi
Chief, general surgery department
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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012/2015
Identifier Type: -
Identifier Source: org_study_id
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