- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892435
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
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Alessia Garzi, MD
- Phone Number: +39 0574804612
- Email: alessia.garzi@gmail.com
Study Contact Backup
- Name: Marco Scatizzi, MD
- Phone Number: +39 0574804612
- Email: fferoci@usl4.toscana.it
Study Locations
-
-
Po
-
Prato, Po, Italy, 59100
- Recruiting
- Misericordia e Dolce Hospital
-
Contact:
- Francesco Feroci, MD
- Phone Number: +393398382381
- Email: fferoci@yahoo.it
-
Sub-Investigator:
- Luca Romoli, MD
-
Sub-Investigator:
- Andrea Vannucchi, MD
-
Principal Investigator:
- Alessia Garzi, MD
-
Sub-Investigator:
- Tiku Zalla, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- abdominal surgery
- open surgery
- contaminated or dirty surgery
Exclusion Criteria:
- not abdominal surgery
- mininvasive surgery
- clean surgery
Study Plan
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
|
positioning incisional negative pressure therapy over closed wound.
Other Names:
|
Active Comparator: Control arm
patients underwent to contaminated/dirty surgery who positioned 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
Sponsor
Investigators
- Principal Investigator: Francesco Feroci, MD, Ospedale Santo Stefano Prato
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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.
Clinical Trials on Wound Healing
-
University of Witten/HerdeckeKCI Europe Holding B.V.CompletedImpaired Wound Healing | Wound Healing Disorder | Abdominal Wound Healing Disorder | Abdominal Wound Healing Impairment | Acute Postsurgical Subcutaneous WoundBelgium, Germany
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingWound Healing | Palate; WoundBrazil
-
Stratpharma AGUniversity Hospital, GenevaCompleted
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedWound HealingUnited States
-
University Hospital, GhentCompleted
-
Dow University of Health SciencesUnknown
-
Peking University Third HospitalCompleted
-
University of ChicagoCompleted
-
Bispebjerg HospitalThe Danish Medical Research CouncilCompletedWound HealingDenmark
Clinical Trials on incisional negative pressure wound therapy
-
DeRoyal Industries, Inc.Lincoln Memorial UniversityCompletedSkin Sensitisation | Skin Reaction to Mechanical, Thermal and Radiation StimuliUnited States
-
Dr. J. WerierRecruitingSoft-tissue Sarcoma | Wound ComplicationCanada
-
Major Extremity Trauma Research ConsortiumNot yet recruitingWound Heal | Wound Complication | Wound Dehiscence | Fracture of Tibia | Infected Wound
-
Ruhr University of BochumCompletedSoft Tissue Sarcoma | Tumor | LipomaGermany
-
Centro Hospitalar do Tâmega e SousaActive, not recruitingSurgical Wound | Surgical Wound Infection | Surgical Site Infection | Surgical Wound, Healed | Surgical Complication | Surgical Wound Dehiscence | Surgical Wound HaemorrhagePortugal
-
McMaster UniversityRecruitingVentral HerniaCanada
-
Chang Gung Memorial HospitalCompleted
-
Odense University HospitalHvidovre University Hospital; Smith & Nephew, Inc.; University of Southern Denmark and other collaboratorsCompletedSurgical Wound Infection | Cesarean Section; Dehiscence | Complications; Cesarean Section | Infection; Cesarean Section | Complications; Cesarean Section, Wound, Dehiscence | Wound; Rupture, Surgery, Cesarean SectionDenmark
-
University of British ColumbiaUnknownSurgical Site Infection | Hematoma | Seroma | Wound Complication | Wound Dehiscence
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States