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

Not Applicable

• Conditions: Acute Wounds
• Interventions: Device: SoftOx Wound Irrigation Solution

• Registration Number: NCT03742284
• Lead Sponsor: SoftOx Solutions AS

Brief Summary

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

Detailed Description

This is a pilot study with an open-label, exploratory study design with the aim to document preliminary safety and performance of the SoftOx Wound Irrigation Solution while used as intended by the manufacturer, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds. This first-in-man study will give valuable information on the feasibility of the treatment with the SoftOx Wound Irrigation Solution to prepare for continuous studies in clinically significant settings prior CE marking. The investigation population will consist of 12 subjects undergoing split skin graft transplantation for treating chronic leg ulcers and that are fulfilling the eligibility criteria for the clinical investigation. The SoftOx Wound Irrigation Solution will be applied on the donor site of the split skin graft which is a representative model of acute wounds in a controlled setting. All subjects will be followed up for 21 days. The duration of the investigation is estimated to 4 months.

Study Timeline

• Study Start: 2018-11-12
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-05
• Primary Completion: 2019-05-31
• Study Completion: 2019-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

1. Participating in any other clinical investigation
2. On systemic immunomodulating drugs
3. On systemic steroid treatment up to four (4) weeks prior to study inclusion
4. On strong pain medication (e.g. opioids)
5. Severe neuropathy (or dysesthesia on the donor site)
6. Pregnancy
7. Dementia
8. Allergy to polyurethane foam, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
- The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution	Evaluation over 21 days	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.

Trial Locations

Locations (1)

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark