One-step Application of Artificial Dermis

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Wounds and Injuries

Treatments: Device: Lando® artificial dermal regeneration matrix

Study type: Observational

Funder types: Other

Identifiers

NCT05666830

NFEC-2021-033

Details and patient eligibility

About

The goal of this observational study is to study the effectiveness of one-step application of Lando® artificial dermal regeneration matrix for burn and plastic wound repair.

The main question it aims to answer is: the effectiveness of one-step application of Lando® artificial dermal regeneration matrix, including the take rate of skin graft and the appearance recovery of the wound.

Participants will be treated with artificial dermis that perfomed with STSG simultaneously. According to the routine clinical practice, the take rate of split-thickness skin graft at about 2-3 weeks and the appearance recovery of the wound at 3 months and 6 months after the implantation were measured.

Enrollment: 37 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≤ 70 years old.
2. Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that need to be repaired and reconstructed by artificial dermis.
3. Patients who voluntarily participate in this clinical trial and sign the informed consent form. When the subjects are under 18 years old or they have no capacity or limited capacity, they should have the consent and signature of the guardian or legal representative.

Exclusion criteria

1. Patients who need to participate in other clinical researchers within 30 days before or during the period of joining the group.
2. Patients with poor control of diabetes (those with fasting blood glucose ≥ 7.0mmol/L or glycosylated hemoglobin HbA1c ≥ 12% after drug control, transaminase > 1.5 times and other diabetic complications).
3. Other cases that researchers believe not suitable for the participants of the trial.

Trial design

37 participants in 1 patient group

1

Description:

Participants will be treated with artificial dermis that perfomed with STSG simultaneously.

Treatment:

Device: Lando® artificial dermal regeneration matrix