Askina Calgitrol Paste Burns

Third Degree Burns Clinical Trial

Official title:

Non-controlled Prospective Cohort Study of the Use of Askina® Calgitrol® Paste on III Degree Burns in Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01911858
• Other study ID #: OPM-G-H-1204
• Status: Withdrawn
• Phase: Phase 3
• First received: July 25, 2013
• Last updated: August 21, 2014
• Start date: April 2013

Study information

• Verified date: August 2014
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Burns
• Third Degree Burns

Intervention

Device:
• Askina Calgitrol Paste

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quantification of the amount of silver found in plasma during the treatment		Change from Baseline in Blood at 3 days	Yes
Primary	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)	Yes
Secondary	Wound bed and periwound skin conditions	Data will not be recorded at specific time points due to individual changing patterns. The investigator will make a subjective description of the wound bed covered by necrosis, slough/fibrin, granulation tissue and epithelialisation and by the condition of the peri-wound skin.	At each dressing change (an expected average of one day)	Yes
Secondary	Clinical signs of infection	Data will not be recorded at specific time points due to individual changing patterns.; The presence and intensity of clinical signs of infection will be assessed at the start of the study and at each dressing change using clinical judgment and a scoring system modified from the one published by Trial and al.	At each dressing change (an expected average of one day)	Yes
Secondary	Patient comfort	Data will not be recorded at specific time points due to individual changing patterns.; The investigator will complete a Likert scale score (1-4, Poor, Fair, Good, Excellent) for each ease of application and ease of removal of Askina Calgitrol Paste at each dressing change.	At each dressing change (an expected average of one day)	No
Secondary	Number of dressing changes	Data will not be recorded at specific time points due to individual changing patterns.	At each dressing change (an expected average of one day)	No
Secondary	Adverse Events or Adverse device related event		At each dressing change	Yes