NCT03742284

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

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: SoftOx Solutions AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Wounds

Interventions

Type	Name	Description
DEVICE	SoftOx Wound Irrigation Solution	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.

Timeline

• Start date: 2018-11-12
• Primary completion: 2019-05-31
• Completion: 2019-06-15
• First posted: 2018-11-15
• Last updated: 2019-03-05

Locations

1 site across 1 country: Denmark