Wound Healing MedDRA version: 8.1 Level: LLT Classification code 10036892 Term: Promotion of wound healing
Conditions
Interventions
Product Name: Zesteem
Product Code: RN1002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Estradiol
CAS Number: 50-28-2
Current Sponsor code: RN1002
Concentration unit: µg/µl microgr
Sponsors
Renovo Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18-85 years who have provided written informed consent. - Patients requiring skin grafting due to burns, trauma or chronic venous ulcers, with a donor site expected to be between 20 and 200 cm2 on a non-articulated area. - Female patients of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose. 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: - Patients with burns involving more than 15% of their total body area. - Patients with sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery. - Patients with inhalation injury requiring artificial respiratory assistance. - Patients requiring skin grafts following removal of suspicious skin lesions. - Patients who have received treatment with systemic steroids during the 30 days prior to surgery. - Patients who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to surgery. - Patients with a history of malignancy in the previous three years. - Patients with uncontrolled diabetes or diabetic ulcers. - Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy. - Patients who have previously had skin grafts harvested from the area to be studied. - Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial. - Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial. - Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. - Patients undergoing investigations or changes in management for an existing medical condition. - Patients who are or who become pregnant up to and including Day 0 or who are lactating. - In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Zesteem on the healing of split thickness skin graft donor sites.;Secondary Objective: To assess the safety and tolerance of Zesteem when administered intradermally before harvest of split thickness skin grafts. To assess the “take” of split thickness skin grafts harvested following intradermal administration of Zesteem to the skin graft donor site. ;Primary end point(s): The primary trial endpoint will be the time to complete wound closure at the skin graft donor site as assessed by the investigating physician or trial nurse. | — |
Countries
Germany, Latvia, United Kingdom
Outcome results
None listed