Wound healing
Conditions
Interventions
Trade Name: Traumaplant - Cream
Product Name: Traumaplant-Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Symphytum herb extract (plant extract)
Other descriptive name: Comfrey extract
Concentra
Sponsors
HARRAS Pharma Curarina Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Superfacial abrasions and wounds of the skin Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Injuries where topical therapy is inadequate and which have to be treated in other way: 1. Polytrauma patient and/or severe accident requiring surgical intervention 2. Target abrasion requiring surgical debridement and/or sutures 3. Deep and/or heavily bleeding wound 4. Already superinfected target abrasion 5. Microcirculatory disorders caused by systemic diseases (e.g. diabetes mellitus) 6. Pre-treatment with local drugs within 12 hours before inclusion in the study (exception: cleaning with water) 7. Patient with a known hypersensitivity against a component of the emulsion cream base: mono- and diglyceride of palmitic and stearic acid, polyoxylethylene-glycerole-monostearate, isopropylmyristate, propyleneglycol, 2-octyldodecanol, dimeticone, alpha-tocopherol acetate, rosemary oil, citric acid, preservatives, 2-hydroxyethyl salicylate, sorbic acid) 8. Allergic, infectious, or inflammatory skin disease in the area of application
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy and time in the acceleration of wound healing in children ;Secondary Objective: Local tolerability on the skin;Primary end point(s): Healing (epithelising) effect by measuring of the area of abrasion before and after tratment (the rate of abrasion decrease degree). | — |
Countries
Czech Republic
Outcome results
None listed