Last reviewed · How we verify
NCT04771819
Safety and Performance of SWIS in Superficial Wounds
NA trial testing SWIS in Wound of Skin in 20 participants. Completed in 20 July 2021.
30 March 2021
Quick facts
| Lead sponsor | SoftOx Solutions AS |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 16 November 2020 |
| Primary completion | 30 March 2021 |
| Estimated completion | 20 July 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- SWIS
Conditions studied
- Wound of Skin — all drugs for Wound of Skin →
Sponsor
SoftOx Solutions AS — full company profile →
Who can join
Adults 18 to 60, any sex, with Wound of Skin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of Stabilized Hypochlorous Acid on Re-epithelialization and Bacterial Bioburden in Acute Wounds: A Randomized Controlled Trial in Healthy Volunteers.
Burian EA, Sabah L, Kirketerp-Møller K, Gundersen G, et al · · 2022 · cited 13× · PMID 35578822 · DOI 10.2340/actadv.v102.1624 -
Reactive oxygen species in health and disease.
Ren Y, Li J, Dai X. · · 2026 · PMID 41824175 · DOI 10.1186/s43556-026-00419-2
Verify or expand the search:
- PubMed search for NCT04771819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Wound of Skin
Currently open trials in the same condition.
- NCT07079774 — TrueLok Elevate PMCF Study · recruiting
- NCT06497712 — BEnefit of HYpnosis on Pain During Stitches in Emergency Room · NA · recruiting
- NCT05462860 — Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds · NA · recruiting
- NCT05608317 — A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing · NA · recruiting
- NCT05074238 — Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects · NA · active not recruiting
Other SoftOx Solutions AS trials
Trials by the same sponsor.
- NCT05710094 — Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds · Phase 1 · completed
- NCT05188638 — Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects · Phase 1 · completed
- NCT03742284 — Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04771819 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SoftOx Solutions AS
- Last refreshed: 19 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04771819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing