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OpenTrials
Completed

NCT Number: NCT04771819

Safety and Performance of SWIS in Superficial Wounds

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.

Completed

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Participating in any other clinical investigation
  • 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
  • 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
  • Daily smoker
  • Pregnancy
  • Systemic immunosuppressive treatment
  • Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator
  • Allergy to 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

Treatment and study plan

SWIS

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.

Primary outcomes

  1. Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound

    Time frame: From baseline to day 10

    Measure the degree of re-epithelialization to evaluate any differences between the treatments.

Secondary outcomes

  1. Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound.

    Time frame: From baseline to day 4

    Evaluate any differences between the two treatments on early epithelialization.

  2. Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound

    Time frame: Day 10

    Evaluate any differences between the two treatments on day 10

  3. Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound

    Time frame: Day 17

    Evaluate any differences between the two treatments on day 17

  4. Percentage of suction blister wounds with >30% CFU reduction in the SWIS treated wound and NS treated wound respectively if positive CFU level prior irrigation

    Time frame: Day 4

    Evaluate any differences between the two treatments on reducing bacterial load in wounds

  5. Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound

    Time frame: Baseline (day 0), day 2 and day 4

    Evaluate any differences on pain using VAS scale between the SWIS and Normal Saline during irrigation and moistening on day 0,2 and 4.

  6. The incidence and severity of adverse events

    Time frame: Baseline to day 17

    Evaluate any differences between the two treatments regarding side effects

Sponsors and collaborators

Lead sponsor

SoftOx Solutions AS

Industry

Registry information

Official study title

Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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