Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04042259

Delayed Primary Closure Using Negative Pressure Wound Therapy

Led by Medical College of Wisconsin · Updated on 2024-12-05

350

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Delayed Primary Closure Using Negative Pressure Wound Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Underwent midline laparotomy and managed with an open abdomen for at least one day
  • Contaminated or dirty wound classification
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

Loading map...

Research Team

C

Colleen Trevino, MSN, FNP, PHD

CONTACT

M

Margo Mantz-Wichman, BS, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Delayed Primary Closure Using Negative Pressure Wound Therapy | DecenTrialz