Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy (OPTIWOUND)
Primary Purpose
Surgical Site Infection, Surgical Wound, Surgical Wound Infection
Status
Active
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Incisional negative pressure wound therapy
Control group - standard wound dressing
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection
Eligibility Criteria
Inclusion Criteria: All patients proposed for emergency laparotomy Exclusion Criteria: Contra-indication for iNPWT Irreversible disease diagnosis with expected short term mortality Need for a staged procedure
Sites / Locations
- Centro Hospitalar do Tâmega e Sousa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Standard
PICO
PREVENA
Arm Description
Control group which will cover surgical wound with conventional wound dressing
Group that will use Pico® device for wound dressing
Group that will use Prevena® device for wound dressing
Outcomes
Primary Outcome Measures
Surgical site infection
Surgical site infection following emergency laparotomy
Secondary Outcome Measures
Surgical site occurrences
Seroma, hematoma, wound dehiscence
Full Information
NCT ID
NCT05716490
First Posted
January 28, 2023
Last Updated
August 28, 2023
Sponsor
Centro Hospitalar do Tâmega e Sousa
1. Study Identification
Unique Protocol Identification Number
NCT05716490
Brief Title
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
Acronym
OPTIWOUND
Official Title
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar do Tâmega e Sousa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
Detailed Description
A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.
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 with class IV Center for disease control wound type, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Surgical Wound, Surgical Wound Infection, Surgical Complication, Surgical Wound Dehiscence, Surgical Wound Haemorrhage, Surgical Wound, Healed
Keywords
iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Control group which will cover surgical wound with conventional wound dressing
Arm Title
PICO
Arm Type
Experimental
Arm Description
Group that will use Pico® device for wound dressing
Arm Title
PREVENA
Arm Type
Experimental
Arm Description
Group that will use Prevena® device for wound dressing
Intervention Type
Device
Intervention Name(s)
Incisional negative pressure wound therapy
Intervention Description
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Intervention Type
Other
Intervention Name(s)
Control group - standard wound dressing
Intervention Description
Covering of surgical wound with standard wound dressing
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Surgical site infection following emergency laparotomy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Surgical site occurrences
Description
Seroma, hematoma, wound dehiscence
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Length of stay
Description
post-operative length of stay
Time Frame
30 days
Title
Reinterventions
Time Frame
30 days
Title
Adverse events related to devices
Time Frame
30 days
Title
Surgical complications
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients proposed for emergency laparotomy
Exclusion Criteria:
Contra-indication for iNPWT
Irreversible disease diagnosis with expected short term mortality
Need for a staged procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo J Costa, MD
Organizational Affiliation
Centro Hospitalar do Tâmega e Sousa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar do Tâmega e Sousa
City
Penafiel
State/Province
Porto
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
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