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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02892435
Other study ID # 012/2015
Secondary ID
Status Recruiting
Phase Phase 2
First received May 19, 2015
Last updated September 1, 2016
Start date November 2014
Est. completion date December 2017

Study information

Verified date September 2016
Source Ospedale Misericordia e Dolce
Contact Alessia Garzi, MD
Phone 0574804612
Email alessia.garzi@gmail.com
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Device:
incisional negative pressure wound therapy
positioning incisional negative pressure therapy over closed wound.
conventional dressing
positioning conventional dressing

Locations

Country Name City State
Italy Misericordia e Dolce Hospital Prato Po

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

Outcome

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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