Askina Calgitrol Paste Burns

NCT01911858 | Withdrawn Phase 3

• 1 other identifier: OPM-G-H-1204
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Third Degree Burns

Outcome Measures

Primary Outcomes (2)

• The quantification of the amount of silver found in plasma during the treatment

  Change from Baseline in Blood at 3 days

• The quantification of the amount of silver found in plasma during the treatment

  Change from Baseline in Blood immediately after the removal of the last investigational dressing (the day before necrotomy, an expected average between 3-10 days after inclusion)

Secondary Outcomes (5)

• Wound bed and periwound skin conditions

  At each dressing change (an expected average of one day)

• Clinical signs of infection

  At each dressing change (an expected average of one day)

• Patient comfort

  At each dressing change (an expected average of one day)

• Number of dressing changes

  At each dressing change (an expected average of one day)

• Adverse Events or Adverse device related event

  At each dressing change

Study Arms (1)

Askina Calgitrol Paste

EXPERIMENTAL

Device: Askina Calgitrol Paste

Interventions

Askina Calgitrol Paste DEVICE

Askina Calgitrol Paste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 30, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: August 22, 2014

Record last verified: 2014-08