Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Not Applicable

Completed

• Conditions: Gastric Bypass Surgery
• Interventions: Radiation: Non-ionising radiation

• Registration Number: NCT03402347
• Lead Sponsor: RSP Systems A/S

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Study Start: 2019-01-01
• Primary Completion: 2019-06-16
• Study Completion: 2019-06-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser irradiation regimes	Non-ionising radiation	Non-ionising radiation intervention will be applied to skin explants

Primary Outcome Measures

Name	Time	Method
Thermal damage threshold	Within 3 months	Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.

Trial Locations

Locations (1)

Department of plastic surgery Z OUH; 🇩🇰 Odense, Denmark