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NCT Number: NCT06255990

Clinical and Histological Study of a Novel Dermal Substitute

The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects.

The main questions aim to answer are:

• Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.

Recruiting

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Key information

Conditions

Skin Transplantation

Age range

1 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantonal Hospital Aarau, Aarau, Canton of Aargau, Switzerland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 1 to 75 years
  • Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG:
  • Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition
  • Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures
  • Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas
  • Informed consent by patients/parents or other legal representative

Exclusion criteria

  • Infected wounds needing surgical procedure other than a dermal template
  • Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin disease, any kind of congenital defect of metabolism including diabetes)
  • Previous enrolment of the patient into the current study
  • Adolescent/Adult patients or in case of children their parents/legal representatives unable to comply with the study protocol
  • Pregnant or breast feeding females

Treatment and study plan

Standard of care

Other

Standard of care

Primary outcomes

  1. Skin elasticity after 1year post-transplantation

    Time frame: 1 year post-transplantation

    Comparison of skin elasticity of treated skin versus adjacent normal skin

Secondary outcomes

  1. Histological staining

    Time frame: within 1 year after skin transplantation

    Histological characterisation of epidermal and dermal components

  2. Skin color assessment

    Time frame: within 1 year after skin transplantation

    Changes in skin color

  3. Photographical assessment

    Time frame: within 1 year after skin transplantation

    Changes in graft-size

  4. Change of quality of life within one year after skin transplantation

    Time frame: within 1 year after skin transplantation

    Quality of life assessed with standard EuroQoL questionnaire

  5. Immunohistochemical analyses

    Time frame: 14-21 days after BTM transplantation

    Histological characterisation of mature BTM

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Böttcher, MD

CONTACT

[email protected]

+41442497228

Vivienne Woodtli, dipl. med.

CONTACT

[email protected]

+41442497586

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • Kantonsspital Aarau
  • Kantonsspital Winterthur KSW
  • University of Zurich

Registry information

Official study title

Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 13, 2024
Registry last updated
Apr 3, 2026

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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