One-step Application of Artificial Dermis

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05666830
• Other study ID #: NFEC-2021-033
• Status: Completed
• Start date: January 28, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• Lando® artificial dermal regeneration matrix
Participants will be treated with artificial dermis that perfomed with STSG simultaneously.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Take rate of skin graft	The percentage of the area of survival skin graft assessed by the Investigator.	2~3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Vancouver Scar Scale score of donor site	Vancouver Scar Scale score of donor site after 3 months assessed by the Investigator.	3 months
Secondary	Vancouver Scar Scale score of donor site	Vancouver Scar Scale score of donor site after 6 months assessed by the Investigator.	6 months
Secondary	Percentage of wound contraction	The Percentage that the area of skin grafting area divided by the original area.	3 months
Secondary	Percentage of wound contraction	The Percentage that the area of skin grafting area divided by the original area.	6 months