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Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds

NCT03742284 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-03-05

No results posted yet for this study

Summary

This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.

Conditions

  • Acute Wounds

Interventions

DEVICE

SoftOx Wound Irrigation Solution

The SoftOx Wound Irrigation Solution is a Medical device that contains a combination of hypochlorous acid and acetic acid in purified water. SWIS is primary intended for mechanical irrigation of acute wounds whereas hypochlorous acid acts as a ancillary medicinal (drug) substance with potential antimicrobial effects. Acute wounds will be rinsed according to protocol and safety (AEs/ADEs/SAEs/SADEs) is the primary objective.

Sponsors & Collaborators

  • SoftOx Solutions AS

    lead INDUSTRY

Principal Investigators

  • Ewa A Burian, MD · Bispebjerg Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2019-05-31
Completion
2019-06-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742284 on ClinicalTrials.gov