NCT00156988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

August 10, 2009

Status Verified

August 1, 2009

First QC Date

September 8, 2005

Last Update Submit

August 7, 2009

Conditions

Burns

Keywords

burnspartial thicknesscerium flamazinerandomised clinical trial

Outcome Measures

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

Interventions

cerium nitrate-silver sulfadiazine (cerium-flamazine)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients having partial thickness burns with TBSA of \< 10%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burns Centre, Martini Hospital

Groningen, 9728NZ, Netherlands

Location

MeSH Terms

Conditions

Burns

Interventions

cerous nitrate, sulfadiazine silver drug combination

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Marianne K Nieuwenhuis, PhD

    Association Dutch Burns Centres

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2004

Study Completion

December 1, 2005

Last Updated

August 10, 2009

Record last verified: 2009-08

Locations

NL(1)