Impact of Active Thermoregulation on the Microcirculation of Free Flaps

This study evaluates the impact of active thermoregulation on free flap microcirculation following free flap transfer. Thermoregulation is performed by passive warming, active warming (water circulation based device) and active cooling. Changes in microcirculation are assessed using combined laser Doppler flowmetry and remission spectroscopy.

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Key information

Conditions

Microcirculation Free Flap Thermoregulation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany

Munich, Bavaria, 81925, Germany

About this study

Measurements are conducted at the day of the operation as well as the first three days following the operation. Tissue temperature is assessed by a temperature measurement probe that is placed 8 mm underneath the skin. The microcirculation parameters of free perforator flaps are assessed using combined laser Doppler flowmetry and remission spectroscopy (O2C®). This allows non-invasive measurement of blood flow, capillary venous oxygen saturation and relative postcapillary filling pressure using a fiber optic probe that is placed on the flap surface. Controlled Thermoregulation (between 10 and 38°C) is enabled using a water circulation based system (Hilotherm Clinic®).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients receiving free perforator flaps with a skin island not less than 4x4 cm

Exclusion criteria

non-compliance,
non-consent,
history of cardiac disease,
arterial hypo- or hypertension,
intake of vasoactive drugs,
peripheral arterial occlusive disease,
chronic kidney and liver disease,
vasculitis

Treatment and study plan

Hilotherm Clinic®

Device

Controlled Thermoregulation using a water circulation based system (Hilotherm Clinic®). Controlled Thermoregulation with Hilotherm Clinic® - Flap Temperature is altered by passive warming (dressing), active warming (38 C) and active cooling (10 C) each for 60 minutes following free flap transfer in every subject at the day of surgery and the following three days

Primary outcomes

Blood Flow (AU) measured by Doppler flowmetry and remission spectroscopy (Oxygen to See, O2C®, Lea Medizintechnik, Giessen, Germany)

Time frame: Measurements were conducted at the day of the operation

Sponsors and collaborators

Lead sponsor

Ulf Dornseifer, MD

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Jun 9, 2015
Registry last updated: Jul 7, 2015

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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Completed