One-step Application of Artificial Dermis

A Study to Observe the Effect of One-step Application of Artificial Dermis on Burn and Plastic Wounds

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Lando® artificial dermal regeneration matrix

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that require repair and reconstruction of dermal defects.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Participants will be treated with artificial dermis that perfomed with STSG simultaneously.	Device: Lando® artificial dermal regeneration matrix; Participants will be treated with artificial dermis that perfomed with STSG simultaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Take rate of skin graft	The percentage of the area of survival skin graft assessed by the Investigator.	2~3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective rate of skin grafting	The rate that the number of cases with excellent or good result divided by the total cases participated. Excellent：take rate of skin graft>90%； Good：take rate of skin graft between 81% and 90%； Fair：take rate of skin graft between 61% and 80%； Poor：take rate of skin graft<60%。	2~3 weeks
Vancouver Scar Scale score of skin grafting site	Vancouver Scar Scale score of skin grafting site after 3 months assessed by the Investigator.	3 months
Vancouver Scar Scale score of skin grafting site	Vancouver Scar Scale score of skin grafting site after 6 months assessed by the Investigator.	6 months
Vancouver Scar Scale score of donor site	Vancouver Scar Scale score of donor site after 3 months assessed by the Investigator.	3 months
Vancouver Scar Scale score of donor site	Vancouver Scar Scale score of donor site after 6 months assessed by the Investigator.	6 months
Percentage of wound contraction	The Percentage that the area of skin grafting area divided by the original area.	3 months
Percentage of wound contraction	The Percentage that the area of skin grafting area divided by the original area.	6 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Estimate): December 28, 2022

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: NFEC-2021-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We are sorry to declaim that the individual participant data is in a state of confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No