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Safety and Performance of SWIS in Superficial Wounds

NCT ID: NCT04771819

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-07-20

Brief Summary

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This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to CE mark to confirm safety and performance of the SWIS device when used as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.

Detailed Description

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Conditions

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Wound of Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SoftOx Wound Irrigation Solution (SWIS)

Blister wounds will be irrigated and soaked for 15 minutes.

Group Type EXPERIMENTAL

SWIS

Intervention Type DEVICE

Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.

Normal Saline

Blister wounds will be irrigated and soaked for 15 minutes.

Group Type ACTIVE_COMPARATOR

SWIS

Intervention Type DEVICE

Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.

Interventions

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SWIS

Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy and intact skin where the blister suction wounds will be induced
* Been informed of the nature, the scope and the relevance of the clinical investigation
* Voluntarily agreed to participation and has duly signed the Information Consent Form

Exclusion Criteria

1. Participating in any other clinical investigation
2. Disease that may interfere with the wound healing, e.g. diabetes, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema of the arm, severe obesity, severe psychiatric disease, dementia or previous known wound healing problems, as judged by the investigator
3. Active skin disease, e.g. dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator
4. Daily smoker
5. Pregnancy
6. Systemic immunosuppressive treatment
7. Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator
8. Allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
9. Not able to read or understand Danish
10. Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
11. That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SoftOx Solutions AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SWIS-02

Identifier Type: -

Identifier Source: org_study_id