Negative Pressure Wound Therapy for Abdominal Infections

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

undergone midline laparotomy and managed with an open abdomen for at least one day

18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial compared surgical site infection rates for contaminated or dirty laparotomy wounds between primary and delayed primary closure techniques. It found that, while primary closure resulted in fewer infections, the difference was not significant enough to outweigh the other complications that can arise from primary closure.

Who is the study for?

This trial is for adults who've had a midline laparotomy (a surgical cut down the middle of the abdomen) and have been managed with an open abdomen for at least one day due to contaminated or dirty wounds. Pregnant women, individuals under 18, prisoners, and non-surgical patients cannot participate.Check my eligibility

What is being tested?

The study tests whether using negative pressure wound therapy (NPWT), specifically a device called Abthera, can improve healing in abdominal infections after surgery compared to leaving the abdomen open without NPWT. It aims to see if this method reduces complications like infections.See study design

What are the potential side effects?

While specific side effects are not listed here, NPWT-related side effects generally may include discomfort at the treatment site, skin irritation or infection around the wound edges, bleeding, or tissue damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery with an open abdomen technique for at least a day.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

30 day readmission

30 day wound complication rate

Closure of Fascia

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Historic CohortExperimental Treatment1 Intervention

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 II: Negative Pressure Wound TherapyActive Control1 Intervention

Standardized wound closure with negative pressure therapy.

0 / 2Eligibility criteria met