Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
NCT ID: NCT05716490
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2022-07-01
2023-09-01
Brief Summary
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Detailed Description
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Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.
Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).
Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith \& Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.
Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.
A final consultation was made 30 days postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard
Control group which will cover surgical wound with conventional wound dressing
Control group - standard wound dressing
Covering of surgical wound with standard wound dressing
PICO
Group that will use Pico® device for wound dressing
Incisional negative pressure wound therapy
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
PREVENA
Group that will use Prevena® device for wound dressing
Incisional negative pressure wound therapy
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Interventions
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Incisional negative pressure wound therapy
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Control group - standard wound dressing
Covering of surgical wound with standard wound dressing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Irreversible disease diagnosis with expected short term mortality
* Need for a staged procedure
18 Years
100 Years
ALL
No
Sponsors
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Centro Hospitalar do Tâmega e Sousa
OTHER
Responsible Party
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Marcelo José Maia Azevedo Costa
Principal investigator, general surgery resident
Principal Investigators
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Marcelo J Costa, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Hospitalar do Tâmega e Sousa
Locations
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Centro Hospitalar do Tâmega e Sousa
Penafiel, Porto District, Portugal
Countries
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Other Identifiers
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29/2022
Identifier Type: -
Identifier Source: org_study_id
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