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NCT04042259 · ClinicalTrials.gov registry record · NA
Delayed Primary Closure Using Negative Pressure Wound Therapy
A NA study of Infection Abdominal, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 1
- Study location
NCT04042259 is a NA study of Infection Abdominal that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 350 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04042259, a NA study of Infection Abdominal, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 1
- Study location
Study 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 pressu
Conditions Studied
Interventions
- DEVICE Abthera
- PROCEDURE Open adbdomen for post-laparotomy without NPWT device
Study Locations (1)
Wisconsin
- Froedtert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04042259
The ClinicalTrials.gov registry entry for NCT04042259 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Infection Abdominal appearing as the primary indexed condition, and to 2 interventions - of which Abthera is the first listed.
NCT04042259 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04042259 about?
NCT04042259 is a clinical study titled "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 surgi...
What is the current status of trial NCT04042259?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2020-08-03. Estimated completion is 2025-12.
What conditions does trial NCT04042259 study?
This clinical trial studies the following conditions: Infection Abdominal.
What interventions are being tested in trial NCT04042259?
The interventions under investigation include: Abthera (DEVICE), Open adbdomen for post-laparotomy without NPWT device (PROCEDURE).
Who is sponsoring clinical trial NCT04042259?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04042259 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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