A multi-center randomized controlled trial for Lando artificial dermal regeneration matrix for dermal reconstruction

A randomized, single-blinded, parallel, positive controlled, and multi-center trial for the efficacy and safety of Lando artificial dermal regeneration matrix for dermal reconstruction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021603

Enrollment

Unknown

Registered

2019-02-28

Start date

2014-08-22

Completion date

Unknown

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wounds with dermal defects

Interventions

Experimental group:Treated with Lando artificial dermal regeneration matrix

Positive Control group:Treated with Pelnac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Subjects with dermal defects and requiring dermal reconstruction; (2) Subjects with the informed consent signed by their legal guardian in case of under 18 years of age or without disposing capacity or with limited disposing capacity; (3) Subjects with burns measuring no larger than 30% of total body surface area (TBSA); (4) Subjects with dermal defects measuring no larger than 10% of TBSA; (5) Subjects with artificial dermal substitutes coverage measuring no larger than 600 cm2; (6) Voluntary participation and sign on the the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe wound infection at the wound site; (2) Patients with dermal defects caused by chronic illness; (3) Patients with poorly controlled diabetes; (4) Patients with wound beds that were not thoroughly debrided; (5) Patients with complicated comorbidities such as heart, brain, blood vessel, liver, kidney disease, hematopoietic systemic disease, or other serious primary disease; (6) Patients with serious necrosis on injured limbs after admission; (7) Patients with medical histories such as coagulation disorders, infectious diseases, poor general condition, and severe medical diseases, or patients with cardiac pacemakers; (8) Patients who had participated in other clinical trials within 3 months before joined in the trial; (9) Other cases that researchers believe not suitable for the participants of the trial.

Design outcomes

Primary

Measure	Time frame
Survival rate of skin graft;Scar;	—

Secondary

Measure	Time frame
Scar;Blood routine examination;Liver function tests;Renal function tests;Complication rate;	—

Countries

China

Contacts

Public ContactZhaofan Xia

Shanghai Changhai Hospital

xiazhaofan@163.com+86 13386273783

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026