Status:

COMPLETED

Randomized Double-Blind Controlled Clinical Trial

Lead Sponsor:

SerenaGroup, Inc.

Collaborating Sponsors:

Anacapa Technologies Inc

Conditions:

Chronic Wounds

Acute Wounds

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds.

Detailed Description

The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds. Using the ...

Eligibility Criteria

Inclusion

  • Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
  • A signed and dated informed consent form.
  • Subject is willing and able to comply with instructions and scheduled visits.

Exclusion

  • The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
  • The subject's wound has not been present for at least 4 weeks.

Key Trial Info

Start Date :

May 20 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2022

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT04320628

Start Date

May 20 2020

End Date

March 1 2022

Last Update

March 14 2022

Active Locations (1)

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Serena Group Research Institute

Pittsburgh, Pennsylvania, United States, 15222