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

This study has been completed.
Sponsor:
Collaborator:
Dutch Burns Foundation
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00156988
First received: September 8, 2005
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Burns
Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns

Resource links provided by NLM:


Further study details as provided by Association of Dutch Burn Centres:

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

Study Start Date: March 2004
Estimated Study Completion Date: December 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156988

Locations
Netherlands
Burns Centre, Martini Hospital
Groningen, Netherlands, 9728NZ
Sponsors and Collaborators
Association of Dutch Burn Centres
Dutch Burns Foundation
Investigators
Principal Investigator: Marianne K Nieuwenhuis, PhD Association Dutch Burns Centres
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156988     History of Changes
Other Study ID Numbers: WO/P04.103, WO/P04.103
Study First Received: September 8, 2005
Last Updated: August 7, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
burns
partial thickness
cerium flamazine
randomised clinical trial

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Silver Sulfadiazine
Cerium nitrate
Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats

ClinicalTrials.gov processed this record on September 22, 2014