Delayed Primary Closure Using Negative Pressure Wound Therapy

NCT04042259 | Recruiting FDA Device

• 1 other identifier: PRO00032783
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

Standardized wound closure with negative pressure therapy.

Device: Abthera

Historic Cohort

OTHER

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

Interventions

Abthera DEVICE

Negative Pressure Wound Therapy Device

Also known as: VERAFLO, Prevena

Negative Pressure Wound Therapy

Open adbdomen for post-laparotomy without NPWT device PROCEDURE

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

Historic Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Colleen Trevino, MSN, FNP, PHD

CONTACT

414-955-1726; ctrevino@mcw.edu

Margo Mantz-Wichman, BS, RN

CONTACT

414-950-1751; mmantzwichman@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 1, 2019
• Study Start: August 3, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (1)