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Completed

NCT Number: NCT00156988

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

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.

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Key information

Conditions

Burns Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Burns Centre, Martini Hospital

Groningen, 9728NZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cerium nitrate-silver sulfadiazine (cerium-flamazine)

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Collaborators

  • Dutch Burns Foundation

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Aug 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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