Delayed Primary Closure Using Negative Pressure Wound Therapy

NCT ID: NCT04042259

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2025-12-31

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.

Conditions

Infection Abdominal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative Pressure Wound Therapy

Standardized wound closure with negative pressure therapy.

Group Type: ACTIVE_COMPARATOR

Abthera

Intervention Type: DEVICE

Negative Pressure Wound Therapy Device

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.

Group Type: OTHER

Open adbdomen for post-laparotomy without NPWT device

Intervention Type: PROCEDURE

Historic cohort treatment of open abdomen for dirty wounds without use of negative pressure therapy device

Interventions

Abthera

Negative Pressure Wound Therapy Device

Intervention Type: DEVICE

Open adbdomen for post-laparotomy without NPWT device

Historic cohort treatment of open abdomen for dirty wounds without use of negative pressure therapy device

Intervention Type: PROCEDURE

Other Intervention Names

VERAFLO; Prevena

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Colleen M Trevino PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colleen Trevino, MSN, FNP, PHD

Role: CONTACT

Phone: 414-955-1726

Email: ctrevino@mcw.edu

Margo Mantz-Wichman, BS, RN

Role: CONTACT

Phone: 414-950-1751

Email: mmantzwichman@mcw.edu

Facility Contacts

Colleen Trevino, FNP PhD

Role: primary

Other Identifiers

PRO00032783

Identifier Type: -

Identifier Source: org_study_id