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The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns

Primary Purpose

Burns

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
cerium nitrate-silver sulfadiazine (cerium-flamazine)
Sponsored by
Association of Dutch Burn Centres
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burns focused on measuring burns, partial thickness, cerium flamazine, randomised clinical trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients having partial thickness burns with TBSA of < 10% Exclusion Criteria: patients not seen within 24 hours postburn patients with only facial burns patients with electrical or chemical burns patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent

Sites / Locations

  • Burns Centre, Martini Hospital

Outcomes

Primary Outcome Measures

number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed

Secondary Outcome Measures

Wound colonisation, assessed by swabs taken at 0 or 3 days pb, 7 days pb and subsequently every 7 days until wounds are healed or treated surgically, and on indication

Full Information

First Posted
September 8, 2005
Last Updated
August 7, 2009
Sponsor
Association of Dutch Burn Centres
Collaborators
Dutch Burns Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00156988
Brief Title
The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
Official Title
The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Association of Dutch Burn Centres
Collaborators
Dutch Burns Foundation

4. Oversight

5. Study Description

Brief Summary
The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
Detailed Description
Cerium is suggested to halt the cytokine cascade ensuing burn injury by binding the 'burn toxin' and, when used in combination with silver-sulfadiazine, may enhance its antibacterial effect. Since 1984, the combination of cerium and silver sulfadiazine, flammacerium, has been used in our centre. Current practice is to treat acute, non-facial, burns with daily cleaning and (re-)application of flammacerium for a total of ten days. However, prolonged application of cerium is thought to be unnecessary - it is effective in the early stages after injury- and prolonged application of silver sulfadiazine has a negative effect on wound healing. The objective of the proposed study is therefore, to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burns, partial thickness, cerium flamazine, randomised clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cerium nitrate-silver sulfadiazine (cerium-flamazine)
Primary Outcome Measure Information:
Title
number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed
Secondary Outcome Measure Information:
Title
Wound colonisation, assessed by swabs taken at 0 or 3 days pb, 7 days pb and subsequently every 7 days until wounds are healed or treated surgically, and on indication

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients having partial thickness burns with TBSA of < 10% Exclusion Criteria: patients not seen within 24 hours postburn patients with only facial burns patients with electrical or chemical burns patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne K Nieuwenhuis, PhD
Organizational Affiliation
Association Dutch Burns Centres
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burns Centre, Martini Hospital
City
Groningen
ZIP/Postal Code
9728NZ
Country
Netherlands

12. IPD Sharing Statement

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The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns

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