Askina Calgitrol Paste Burns

Last updated: August 21, 2014
Sponsor: BBraun Medical SAS
Overall Status: Trial Not Available

Phase

3

Condition

Skin Wounds

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01911858
OPM-G-H-1204
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thelatest

  • Patients who underwent initial treatment directly at the Burn Centre of FNKV or theinitial 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

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 consentor who are not capable of giving informed consent

  • Patients who used or were treated with silver products for other reasons thantreatment 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

Study Design

Study Start date:
April 01, 2013
Estimated Completion Date: