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Treatment of non-healing ulcers with a dressing based on a innovative nanomaterial

A clinical trial on patients with non-healing ulcers treated with a modified version of a biosynthetic cellulose named eiratex: Effects on the healing rate, healing time and treatment costs compared to a saline-soaked gauze and other wound dressings.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14756102
Enrollment
8
Registered
2017-08-01
Start date
2016-02-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic lower-extremity venous ulcers or traumatic ulcers were object of this trial Injury, Occupational Diseases, Poisoning Chronic lower-extremity venous ulcers or traumatic ulcers were object of this trial

Interventions

The eiratex® dressing was applied on the wound after surgical debridement, where applicable. The wounds are examined every second day by the attending physician during the first week, and then once pe

Sponsors

Ewecare AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Chronic lower limb wounds that were not healed after 6 weeks from the initial injury 2. Treated with eiratex® for the whole treatment 3. Non-infected and infected ulcers 4. Aged from 62 to 85 years old

Exclusion criteria

Exclusion criteria: 1. Patients with exposure of bone, muscle, ligaments, or tendons 2. Patient with mental disorders were excluded to guarantee a conscious agreement to the participation in this study

Design outcomes

Primary

MeasureTime frame
Healing time is measured by visual examination from the medical doctor. At each treatment visit, information regarding adverse events, medications and other aspects of care since the last visit was acquired.

Secondary

MeasureTime frame
1. Frequency of dressing changes are measured by counting the total number of dressings used during the treatment for each patient, divided by the healing time (in weeks) 2. Number of dressings used are measured by the doctor for each patient. The number of dressings used is related to the number needed to heal the wound

Countries

Sweden

Contacts

Public ContactTobias Sivler
tobias.sivler@s2m.se+46 73 800 88 08

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026