Prevena™ Incision Management System vs Conventional Management for Wound Healing

September 1, 2016 updated by: Marco Scatizzi, Ospedale Misericordia e Dolce

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Po
      • Prato, Po, Italy, 59100
        • Recruiting
        • Misericordia e Dolce Hospital
        • Contact:
        • Sub-Investigator:
          • Luca Romoli, MD
        • Sub-Investigator:
          • Andrea Vannucchi, MD
        • Principal Investigator:
          • Alessia Garzi, MD
        • Sub-Investigator:
          • Tiku Zalla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • abdominal surgery
  • open surgery
  • contaminated or dirty surgery

Exclusion Criteria:

  • not abdominal surgery
  • mininvasive surgery
  • clean surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevena arm
patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days
Device: incisional negative pressure wound therapy
positioning incisional negative pressure therapy over closed wound.
Other Names:
  • Prevena - KCI
Active Comparator: Control arm
patients underwent to contaminated/dirty surgery who positioned conventional dressing
Device: conventional dressing
positioning conventional dressing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Misericordia e Dolce

Investigators

  • Principal Investigator: Francesco Feroci, MD, Ospedale Santo Stefano Prato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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