Delayed Primary Closure Using Negative Pressure Wound Therapy

Not Applicable

Recruiting

• Conditions: Infection Abdominal
• Interventions: Procedure: Open adbdomen for post-laparotomy without NPWT device; Device: Abthera

• Registration Number: NCT04042259
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Study Start: 2020-08-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Historic Cohort	Open adbdomen for post-laparotomy without NPWT device	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.
Negative Pressure Wound Therapy	Abthera	Standardized wound closure with negative pressure therapy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States