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NCT Number: NCT04042259

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infection Abdominal Infections Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abthera

Device

Negative Pressure Wound Therapy Device

Other names: VERAFLO, Prevena

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

Primary outcomes

  1. 30 day wound complication rate

    Time frame: 30 days

    Wound infection, dehiscence, evisceration

  2. 30 day readmission

    Time frame: 30 days

    Patient discharged and readmitted to primary care

  3. Days of Abthera, VERAFLO, and Prevena use

    Time frame: through wound closure, an average of 30 days

    Use of negative pressure wound therapy

  4. Closure of Fascia

    Time frame: 7 days

    Measure of days to closure of fascia

  5. Closure of Skin

    Time frame: 7 days

    Measure of days to closure of skin

  6. Cost of care

    Time frame: days to wound closure an average of 30 days

    Total cost for wound care

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2019
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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