One-step Application of Artificial Dermis

NCT05666830 | Completed

• 1 other identifier: NFEC-2021-033
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Take rate of skin graft

  The percentage of the area of survival skin graft assessed by the Investigator.

  2~3 weeks

Secondary Outcomes (7)

• Effective rate of skin grafting

  2~3 weeks

• Vancouver Scar Scale score of skin grafting site

  3 months

• Vancouver Scar Scale score of skin grafting site

  6 months

• Vancouver Scar Scale score of donor site

  3 months

• Vancouver Scar Scale score of donor site

  6 months

Study Arms (1)

1

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

Device: Lando® artificial dermal regeneration matrix

Interventions

Lando® artificial dermal regeneration matrix DEVICE

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

1

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≤ 70 years old.
• 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.
• 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.

You may not qualify if:

• Patients who need to participate in other clinical researchers within 30 days before or during the period of joining the group.
• 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).
• Other cases that researchers believe not suitable for the participants of the trial.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: January 28, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)