E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036892 |
E.1.2 | Term | Promotion of wound healing |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of Zesteem on the healing of split thickness skin graft donor sites. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The End of Trial is considered to be the last patient / last visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |