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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

August 7, 2009

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00156988 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Burns

Intervention ^ICMJE

Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00156988

Responsible Party

Study ID Numbers ^ICMJE

WO/P04.103, WO/P04.103

Study Sponsor ^ICMJE

Association of Dutch Burn Centres

Collaborators ^ICMJE

Dutch Burns Foundation

Investigators ^ICMJE

Principal Investigator:

Marianne K Nieuwenhuis, PhD

Association Dutch Burns Centres

Information Provided By

Association of Dutch Burn Centres

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP