Prevena™ Incision Management System vs Conventional Management for Wound Healing

Ospedale Misericordia e Dolce

Status and phase: Unknown; Phase 2

Conditions: Dirty Abdominal Surgery; Negative-Pressure Wound Therapy; Contaminated Abdominal Surgery; Prevena; Wound Healing; Emergency Abdominal Surgery

Treatments: Device: conventional dressing; Device: incisional negative pressure wound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02892435

012/2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• abdominal surgery
• open surgery
• contaminated or dirty surgery

Exclusion criteria

• not abdominal surgery
• mininvasive surgery
• clean surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Prevena arm

Experimental group

Description:

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

Treatment:

Device: incisional negative pressure wound therapy

Control arm

Active Comparator group

Description:

patients underwent to contaminated/dirty surgery who positioned conventional dressing

Treatment:

Device: conventional dressing