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Delayed Primary Closure Using Negative Pressure Wound Therapy

Delayed Primary Closure Using Negative Pressure Wound Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04042259
Enrollment
40
Registered
2019-08-01
Start date
2020-08-03
Completion date
2026-07-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Abdominal

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.

Interventions

DEVICEAbthera

Negative Pressure Wound Therapy Device

PROCEDUREOpen adbdomen for post-laparotomy without NPWT device

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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
30 day wound complication rate30 daysWound infection, dehiscence, evisceration
30 day readmission30 daysPatient discharged and readmitted to primary care
Days of Abthera, VERAFLO, and Prevena usethrough wound closure, an average of 30 daysUse of negative pressure wound therapy
Closure of Fascia7 daysMeasure of days to closure of fascia
Closure of Skin7 daysMeasure of days to closure of skin
Cost of caredays to wound closure an average of 30 daysTotal cost for wound care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026