Safety and Efficacy of I-020502 in Meshed Skin Autografting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

NCT04765202

Full Thickness Thermal Burn

TERMINATED PHASE1/PHASE2

Microsurfaced Grafts in Deep Burn Wounds

NCT04589442

Burns Wound Heal

RECRUITING PHASE4

Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds

NCT00161759

Burns

COMPLETED PHASE1/PHASE2

Reducing Side-effects of Autologous Skin Tissue Harvesting

NCT02234193

Scar

COMPLETED EARLY_PHASE1

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

NCT05517902

Skin Wound Burns Trauma-related Wound

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

I-020502

1 mcg/mL TG-PDGF.AB

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 ≥ 5 % and ≤ 50 % 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 cm2.
6. Patients who are willing to comply with treatment applications and instructions by the protocol.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No