Assessing the safety of Linovera® for treating pressure ulcers
Prospective, Multicentre, Single-arm, Controlled Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
This study is testing if Linovera® is safe and effective for treating pressure ulcers in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | B. Braun Medical SA Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oviedo) |
| Trial ID | NCT06183086 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and performance of Linovera® in treating Category-I pressure ulcers. It involves the proactive collection of clinical data to generate evidence supporting the use of Linovera® for this indication. The study will follow adult patients with at least one Category-I pressure ulcer, monitoring their healing process while using Linovera®. The findings will help maintain the product's availability for future patients requiring treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with at least one Category-I pressure ulcer who have not used Linovera® in the past two weeks.
Not a fit: Patients under 18 years old or those with known allergies to Linovera® components will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for patients suffering from Category-I pressure ulcers.
How similar studies have performed: While this study focuses on Linovera®, similar approaches in treating pressure ulcers have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥ 18 years) * Patients with at least one Category-I PU/I (remark: follow-up will be done for one ulcer per patient). * Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the EC prior to all evaluations. * Patient naïve to Linovera® 2 weeks before visit 1 (only applicable to the area of the skin that will be assessed). * Patients which can be potentially followed until their Category-1 pressure ulcer/injury is healed throughout the duration of the study, according to the clinicians opinion. Exclusion Criteria: * Age \<18 years * Known allergies and/or hypersensitivity to any component of Linovera®. * Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures. * Any planned intervention that, in the investigator opinion, may affect skin condition of the patient (e.g. chemotherapy or radiotherapy). * Simultaneous participation in an interventional clinical trial (drugs or medical devices studies). * Any other additional topical treatments applied in the area of the skin that will be assessed.
Where this trial is running
Oviedo
- Hospital Universitario Central de Asturias — Oviedo, Spain (Recruiting)
Study contacts
- Principal investigator: Susana Valerdiz — Hospital Universitario Central de Asturias
- Study coordinator: Aina Fernández
- Email: aina.fernandez@bbraun.com
- Phone: +34 663 895 945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.