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Delayed Primary Closure Using Negative Pressure Wound Therapy

Primary Purpose

Infection Abdominal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abthera
Open adbdomen for post-laparotomy without NPWT device
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection Abdominal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • undergone midline laparotomy and managed with an open abdomen for at least one day
  • contaminated or dirty wound classification

Exclusion Criteria:

  • Less than 18 years of age
  • Prisoners
  • Pregnant females
  • Non-surgical patients

Sites / Locations

  • Froedtert HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Negative Pressure Wound Therapy

Historic Cohort

Arm Description

Standardized wound closure with negative pressure therapy.

Historic cohort have undergone a midline laparotomy and managed with an open abdomen for at least one day and have contaminated or dirty wound classification.

Outcomes

Primary Outcome Measures

30 day wound complication rate
Wound infection, dehiscence, evisceration
30 day readmission
Patient discharged and readmitted to primary care
Days of Abthera, VERAFLO, and Prevena use
Use of negative pressure wound therapy
Closure of Fascia
Measure of days to closure of fascia
Closure of Skin
Measure of days to closure of skin
Cost of care
Total cost for wound care

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
January 10, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04042259
Brief Title
Delayed Primary Closure Using Negative Pressure Wound Therapy
Official Title
Delayed Primary Closure Using Negative Pressure Wound Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Surgical site infection rates for contaminated or dirty laparotomy wounds can be as high as 45%. Surgical management of dirty and contaminated wounds has been controversial in the literature and between surgeons. Primary closure (PC) of these wounds can lead to multiple complications including surgical site infection (SSI), necrotizing soft tissue infection, wound and fascial dehiscence, evisceration, sepsis and hernia development. However, an alternative technique of utilizing secondary intention results in prolonged healing time and increased cost and healthcare resource utilization. Delayed primary closure (DPC) was developed to address many of these issues. Bhangu completed a systematic review and meta-analysis comparing primary versus delayed primary skin closure in contaminated and dirty abdominal wounds. They included 8 studies randomizing 623 patients with contaminated or dirty abdominal wounds to either DPC or PC. The most common diagnosis was appendicitis (77.4%), followed by perforated abdominal viscus (11.5%), ileostomy closure (6.5%), trauma (2.7%), and intra-abdominal abscess/other peritonitis (1.9%). The time to first assessment for DPC was between 2 and 5 days postoperatively. In all studies, the DPC group had significantly less SSIs using a fixed-effect model (odds ratio, 0.65; 95%CI, 0.40-0.93; P = .02). However, heterogeneity was high (72%), and using a random-effects model, the effect was no longer significant (odds ratio, 0.65; 95% CI, 0.25-1.64; P = .36). Additionally, all of the studies were found to be at high risk of bias, with marked deficiencies in study design and outcome assessment. A recent systematic review showed improved fascial closure rates with negative pressure wound therapy (NPWT) Yet, a large national study using NPWT to perform a DPC has been shown to actually decrease the rate of closure. Access to NPWT has increased over the years and innovative wound management techniques including incisional application of negative pressure therapy have allowed clinicians to apply this method to dirty wounds following the principles of delayed primary closure. There are currently no studies available to help determine the safety and efficacy of advanced NPWT techniques to optimize surgical wound management from the open abdomen to skin closure. Within our Division, we have decided to make a practice change and develop a standard closure plan for open abdomens using the negative pressure devices available within our institution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Abdominal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Active Comparator
Arm Description
Standardized wound closure with negative pressure therapy.
Arm Title
Historic Cohort
Arm Type
Other
Arm Description
Historic cohort have undergone a midline laparotomy and managed with an open abdomen for at least one day and have contaminated or dirty wound classification.
Intervention Type
Device
Intervention Name(s)
Abthera
Other Intervention Name(s)
VERAFLO, Prevena
Intervention Description
Negative Pressure Wound Therapy Device
Intervention Type
Procedure
Intervention Name(s)
Open adbdomen for post-laparotomy without NPWT device
Intervention Description
Historic cohort treatment of open abdomen for dirty wounds without use of negative pressure therapy device
Primary Outcome Measure Information:
Title
30 day wound complication rate
Description
Wound infection, dehiscence, evisceration
Time Frame
30 days
Title
30 day readmission
Description
Patient discharged and readmitted to primary care
Time Frame
30 days
Title
Days of Abthera, VERAFLO, and Prevena use
Description
Use of negative pressure wound therapy
Time Frame
through wound closure, an average of 30 days
Title
Closure of Fascia
Description
Measure of days to closure of fascia
Time Frame
7 days
Title
Closure of Skin
Description
Measure of days to closure of skin
Time Frame
7 days
Title
Cost of care
Description
Total cost for wound care
Time Frame
days to wound closure an average of 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older undergone midline laparotomy and managed with an open abdomen for at least one day contaminated or dirty wound classification Exclusion Criteria: Less than 18 years of age Prisoners Pregnant females Non-surgical patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Trevino, MSN, FNP, PHD
Phone
414-955-1726
Email
ctrevino@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Margo Mantz-Wichman, BS, RN
Phone
414-950-1751
Email
mmantzwichman@mcw.edu
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Trevino, FNP PhD
Phone
414-955-1726
Email
ctrevino@mcw.edu

12. IPD Sharing Statement

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Delayed Primary Closure Using Negative Pressure Wound Therapy

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