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Completed

NCT Number: NCT05666830

One-step Application of Artificial Dermis

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.

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Key information

Conditions

Wounds and Injuries

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lando® artificial dermal regeneration matrix

Device

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

Primary outcomes

  1. Take rate of skin graft

    Time frame: 2~3 weeks

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

Secondary outcomes

  1. Effective rate of skin grafting

    Time frame: 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%。

  2. Vancouver Scar Scale score of skin grafting site

    Time frame: 3 months

    Vancouver Scar Scale score of skin grafting site after 3 months assessed by the Investigator.

  3. Vancouver Scar Scale score of skin grafting site

    Time frame: 6 months

    Vancouver Scar Scale score of skin grafting site after 6 months assessed by the Investigator.

  4. Vancouver Scar Scale score of donor site

    Time frame: 3 months

    Vancouver Scar Scale score of donor site after 3 months assessed by the Investigator.

  5. Vancouver Scar Scale score of donor site

    Time frame: 6 months

    Vancouver Scar Scale score of donor site after 6 months assessed by the Investigator.

  6. Percentage of wound contraction

    Time frame: 3 months

    The Percentage that the area of skin grafting area divided by the original area.

  7. Percentage of wound contraction

    Time frame: 6 months

    The Percentage that the area of skin grafting area divided by the original area.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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