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Pilot study, randomised, open-label, monocentre, case vs control study to assess the effect of topically and parenterally Heparin administration treatment in superficial and deep second grade burns patients. - ND

Pilot study, randomised, open-label, monocentre, case vs control study to assess the effect of topically and parenterally Heparin administration treatment in superficial and deep second grade burns patients. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004304-12-IT
Enrollment
Unknown
Registered
2007-10-19
Start date
2007-09-25
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial and deep second degree burns. MedDRA version: 9.1 Level: LLT Classification code 10006802 Term: Burns second degree

Interventions

Product Name: Heparin Pharmaceutical Form: Solution for injection INN or Proposed INN: Heparin Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number

Sponsors

AZIENDA OSPEDALIERA PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. Superficial and deep second degree burns of any cause (heat, fire, burst, liquids, steam, etc.) in any place and any % extension of total corporeal surface in patients of age. b. Age >= 18 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. Burn with trauma with bleeding. b. Family history or history of bleeding. c. Peptic ulcer. d. Thrombocytepenia. e. Heparin hypersensitivity. f. Bleeding. g. Chemical burns.

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare quality of life of burns patients (superficial and deep second degree)treated with heparin to quality of life of burns patients treated with standard surgical treatment.;Secondary Objective: a. Compare process of clinical recovery of burns with heparin treatment to process of clinical recovery of burns with standard surgical treatment, evaluating the next criteria: edema entity, aesthetical-functional aspect of cicatricial results; number of complications of burns. b. Examine treatment groups about the next aspects: quantity of transfused liquids; number of surgical procedures; number of medical procedures; number of day of hospitalization; costs. c. Compare number of local and systemic infections and the course of the illness in patients treated with heparin to number of local and systemic infections and the course of the illness in patients treated with standard surgical treatment.;Primary end point(s): Assessment of analgesic effect of heparin with examination of lack or significant reduction of sedative-analgesic drugs, during all period necessary for recovery.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026