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Prevena™ Incision Management System vs Conventional Management for Wound Healing

Primary Purpose

Wound Healing, Prevena, Dirty Abdominal Surgery

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
incisional negative pressure wound therapy
conventional dressing
Sponsored by
Ospedale Misericordia e Dolce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Healing

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • abdominal surgery
  • open surgery
  • contaminated or dirty surgery

Exclusion Criteria:

  • not abdominal surgery
  • mininvasive surgery
  • clean surgery

Sites / Locations

  • Misericordia e Dolce HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prevena arm

Control arm

Arm Description

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

patients underwent to contaminated/dirty surgery who positioned conventional dressing

Outcomes

Primary Outcome Measures

Surgical Site Infection (SSI) reduction
quantify SSI decrease after incisional negative pressure wound therapy

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2015
Last Updated
September 1, 2016
Sponsor
Ospedale Misericordia e Dolce
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1. Study Identification

Unique Protocol Identification Number
NCT02892435
Brief Title
Prevena™ Incision Management System vs Conventional Management for Wound Healing
Official Title
Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Prevena, Dirty Abdominal Surgery, Contaminated Abdominal Surgery, Emergency Abdominal Surgery, Negative-Pressure Wound Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prevena arm
Arm Type
Experimental
Arm Description
patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
patients underwent to contaminated/dirty surgery who positioned conventional dressing
Intervention Type
Device
Intervention Name(s)
incisional negative pressure wound therapy
Other Intervention Name(s)
Prevena - KCI
Intervention Description
positioning incisional negative pressure therapy over closed wound.
Intervention Type
Device
Intervention Name(s)
conventional dressing
Intervention Description
positioning conventional dressing
Primary Outcome Measure Information:
Title
Surgical Site Infection (SSI) reduction
Description
quantify SSI decrease after incisional negative pressure wound therapy
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer
Description
check connection between wound complications and risk factors and showing if Incisional Negative Pressure Wound Therapy (INPWT) could reduce effects of these risk factors
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: abdominal surgery open surgery contaminated or dirty surgery Exclusion Criteria: not abdominal surgery mininvasive surgery clean surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessia Garzi, MD
Phone
0574804612
Ext
+39
Email
alessia.garzi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Scatizzi, MD
Phone
0574804612
Ext
+39
Email
fferoci@usl4.toscana.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Feroci, MD
Organizational Affiliation
Ospedale Santo Stefano Prato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misericordia e Dolce Hospital
City
Prato
State/Province
Po
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Feroci, MD
Phone
+393398382381
Email
fferoci@yahoo.it
First Name & Middle Initial & Last Name & Degree
Luca Romoli, MD
First Name & Middle Initial & Last Name & Degree
Andrea Vannucchi, MD
First Name & Middle Initial & Last Name & Degree
Alessia Garzi, MD
First Name & Middle Initial & Last Name & Degree
Tiku Zalla, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevena™ Incision Management System vs Conventional Management for Wound Healing

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