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

NCT03742284 | Unknown

• 1 other identifier: CIV-18-08-025365
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• - The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution

  Incidence and severity of any adverse events related to the SoftOx Wound Irrigation Solution will be summarized in terms of frequencies (n), percentages (%) and the mode.

  Evaluation over 21 days

Study Arms (1)

SoftOx Wound Irrigation Solution

OTHER

SoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds.

Device: SoftOx Wound Irrigation Solution

Interventions

SoftOx Wound Irrigation Solution DEVICE

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.

Also known as: SWIS

SoftOx Wound Irrigation Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older
• Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation
• Been informed of the nature, the scope and the relevance of the clinical investigation
• Voluntarily agreed to participation and has duly signed the Informed Consent Form

You may not qualify if:

• Participating in any other clinical investigation
• On systemic immunomodulating drugs
• On strong pain medication (e.g. opioids)
• Severe neuropathy (or dysesthesia on the donor site)
• Pregnancy
• Dementia
• Allergy to polyurethane foam, hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
• Not able to read or understand Danish
• Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
• That according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Sponsors & Collaborators

• SoftOx Solutions AS: lead

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

RECRUITING

Study Officials

• Ewa A Burian, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewa A Burian, MD

CONTACT

+45 53 60 91 59; ewa.anna.burian@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: November 12, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 15, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)