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NCT04840953 Clinical Trial

Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients

Covid19 Clinical Trial

Official title:
Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04840953
Other study ID # ENFIVAC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date February 1, 2021

Study information
Verified date April 2021
Source Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background Numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive SARS COV-2 patients. More effective, less invasive and isolated procedures should be implemented. Technique Negative pressure therapy (NPT) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in Covid-19 or non infected critical patients. Conclusion NPT is an effective and low invasive strategy for the management of EES in critical patients with high risk of mortality.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date February 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Subcutaneous emphysema that compromises ventilation Exclusion Criteria: - Declined Therapy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vçac
VAC THERAPY vs SURGICAL DREINAGE

Locations
Country Name City State
Spain Hospital General Universitario de Elche Elche Alicante

Sponsors (1)
Lead Sponsor Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resolution time of emphysema with negative pressure therapy Days Days
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