Askina Calgitrol Paste Burns

NCT ID: NCT01911858

Last Updated: 2014-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Third Degree Burns

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Askina Calgitrol Paste

Group Type EXPERIMENTAL

Askina Calgitrol Paste

Intervention Type DEVICE

Interventions

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Askina Calgitrol Paste

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BBraun Medical SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OPM-G-H-1204

Identifier Type: -

Identifier Source: org_study_id

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