Delayed Primary Closure Using Negative Pressure Wound Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Infection Abdominal
• Intervention / Treatment: Device: Abthera; Procedure: Open adbdomen for post-laparotomy without NPWT device

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colleen Trevino, MSN, FNP, PHD; Phone Number: 414-955-1726; Email: ctrevino@mcw.edu
• Study Contact Backup: Name: Margo Mantz-Wichman, BS, RN; Phone Number: 414-950-1751; Email: mmantzwichman@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital
      • Contact: Colleen Trevino, FNP PhD; Phone Number: 414-955-1726; Email: ctrevino@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Negative Pressure Wound Therapy; Standardized wound closure with negative pressure therapy.	Device: Abthera; Negative Pressure Wound Therapy Device; Other Names: Prevena; VERAFLO
Other: Historic Cohort; 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.	Procedure: Open adbdomen for post-laparotomy without NPWT device; Historic cohort treatment of open abdomen for dirty wounds without use of negative pressure therapy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day wound complication rate	Wound infection, dehiscence, evisceration	30 days
30 day readmission	Patient discharged and readmitted to primary care	30 days
Days of Abthera, VERAFLO, and Prevena use	Use of negative pressure wound therapy	through wound closure, an average of 30 days
Closure of Fascia	Measure of days to closure of fascia	7 days
Closure of Skin	Measure of days to closure of skin	7 days
Cost of care	Total cost for wound care	days to wound closure an average of 30 days

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Intraabdominal Infections
• Other Study ID Numbers: PRO00032783

Drug and device information, study documents

• 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