E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Deep partial-thickness and full-thickness burns require grafting procedures to achieve wound healing and closure. Autologous grafting eliminates the risk of transmissible diseases but may be complicated by hematoma formation, infection and mechanical disruption. In large total body surface area burns, the skin donor site is quickly exhausted. Meshed skin autografts become a convenient alternative for which the use of I-020502 will be investigated.
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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 | 10053615 |
E.1.2 | Term | Thermal burn |
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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 tolerability and safety of I-020502 on wound healing in patients with deep partial thickness or full thickness burns undergoing autologous meshed skin grafting. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of I-020502 on wound healing and wound closure at the site of the mesh graft, including scar evaluation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent by the patient or his/her legal representative. 2.Male or female, aged ≥ 18 years 3.Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening). 4.Patients with burn wound(s) between ≥ 10 % and ≤ 30 % TBSA. 5.Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 sqcm. 6.Patients who are willing to comply with treatment applications and instructions by the protocol. |
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E.4 | Principal exclusion criteria |
1.Females who are pregnant or breast-feeding. 2.Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins). 3.Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites. 4.Electrical and/or chemical burns. 5.Patients that are judged to have significant pulmonary compromise. 6.Transcutaneous tissue oxygenation < 90%. 7.Clinically significant infections at wound sites. 8.Clinically significant systemic infections. 9.Suspicion or presence of active systemic or local cancer or tumor of any kind. 10.Patients with known immunodeficiency disorders, either congenital or acquired. 11.Patients with vascular or skin disorders that directly affect the designated wound site. 12.Patients with Diabetes mellitus. 13.Patients with chronic malnourishment. 14.Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery. 15.Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion are a contraindication to skin mesh grafting and study participation. 16.Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of treatment-related adverse events, systemic and at the test sites, up to Day 28 after surgery. |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Safety and tolerability study |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Teatments to test sites will be randomized (each person will serve as his/her own control) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
staples for graft fixation (standard of care) |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
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The end of the trial is the last visit of the last patient (12 Months +/-10 days post-surgery). Adverse events will be followed up to resolution. Serious adverse events still ongoing at the End of Study visit will be followed until resolution or stabilization or until the event is otherwise explained. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |