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Completed

NCT Number: NCT03402347

Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.

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Key information

Conditions

Gastric Bypass Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of plastic surgery Z OUH

Odense, 5000, Denmark

About this study

The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subject 18 years of age or older
  • Gastric bypass operated or similar
  • Excess abdominal skin to be removed surgically
  • Abdominal skin tone 4 or below

Exclusion criteria

  • Extensive skin changes, tattoos or diseases on skin explant to be donated
  • Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.

Treatment and study plan

Non-ionising radiation

Radiation

Laser regimes will be applied to ex vivo skin samples.

Primary outcomes

  1. Thermal damage threshold

    Time frame: Within 3 months

    Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.

Sponsors and collaborators

Lead sponsor

RSP Systems A/S

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2018
Registry last updated
Jul 2, 2019

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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