Wound Healing Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - abdominal surgery - open surgery - contaminated or dirty surgery Exclusion Criteria: - not abdominal surgery - mininvasive surgery - clean surgery |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Misericordia e Dolce Hospital | Prato | Po |
Lead Sponsor | Collaborator |
---|---|
Ospedale Misericordia e Dolce |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical Site Infection (SSI) reduction | quantify SSI decrease after incisional negative pressure wound therapy | 7 months | No |
Secondary | 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 | 2 years | No |
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