Askina Calgitrol Paste Burns

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Third Degree Burns
• Intervention / Treatment: Device: Askina Calgitrol Paste

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Askina Calgitrol Paste	Device: Askina Calgitrol Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Adverse Events or Adverse device related event		At each dressing change

Collaborators and Investigators

• Sponsor: BBraun Medical SAS

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (ESTIMATE): July 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: OPM-G-H-1204