Askina Calgitrol Paste Burns

B. Braun

Status and phase: Withdrawn; Phase 3

Conditions: Third Degree Burns

Treatments: Device: Askina Calgitrol Paste

Study type: Interventional

Funder types: Industry

Identifiers

NCT01911858

OPM-G-H-1204

Details and patient eligibility

About

The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥>18 years age). No upper age limit
• III degree thermal burns from 2-30% TBSA as determined by the Rule of Nines
• Patients who underwent initial treatment within 24 hours after the injury at the latest
• Patients who underwent initial treatment directly at the Burn Centre of FNKV or the initial treatment was in accordance with the standard of care of the Centre
• All patients will have been hospitalised
• Patients who are capable of giving signing informed consent and have done so.

Exclusion criteria

• Patients with electrical or chemical burns
• Patients with already infected wounds
• Patients taking systemic antibiotics on admission
• Patients pregnant or lactating
• Patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent
• Patients who used or were treated with silver products for other reasons than treatment of the acute burn in the last 3 months
• Patients whose other burn wounds are being treated with silver products.
• Patients receiving renal dialysis
• Known allergy or sensitivity to any of the ingredients in Askina® Calgitrol® Paste.
• Simultaneous participation in another interventional clinical trial

Trial design

0 participants in 1 patient group

Askina Calgitrol Paste

Experimental group

Treatment:

Device: Askina Calgitrol Paste