One-step Application of Artificial Dermis

Completed

• Conditions: Wounds and Injuries
• Interventions: Device: Lando® artificial dermal regeneration matrix

• Registration Number: NCT05666830
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-12
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Lando® artificial dermal regeneration matrix	Participants will be treated with artificial dermis that perfomed with STSG simultaneously.

Primary Outcome Measures

Name	Time	Method
Take rate of skin graft	2~3 weeks	The percentage of the area of survival skin graft assessed by the Investigator.

Secondary Outcome Measures

Name	Time	Method
Percentage of wound contraction	6 months	The Percentage that the area of skin grafting area divided by the original area.
Vancouver Scar Scale score of skin grafting site	6 months	Vancouver Scar Scale score of skin grafting site after 6 months assessed by the Investigator.
Vancouver Scar Scale score of donor site	6 months	Vancouver Scar Scale score of donor site after 6 months assessed by the Investigator.
Effective rate of skin grafting	2~3 weeks	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%。

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China