Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds — SWIS-01  

Acute Wounds Clinical Trial

Official title: Pilot Study to Document Safety and Performance of SoftOx Wound Irrigation Solution in Patients With Split Skin Wounds (Donor Site) Undergoing Skin Transplantation. A Human Model for Acute Trauma Wounds

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Wounds
• Wounds and Injuries

• NCT number: NCT03742284
• Study type: Interventional
• Source: SoftOx Solutions AS
• Contact: Ewa A Burian, MD
• Phone: +45 53 60 91 59
• Email: ewa.anna.burian@regionh.dk
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2018
• Completion date: June 15, 2019