Impact of Active Thermoregulation on the Microcirculation of Free Flaps

Ulf Dornseifer, MD

Status: Completed

Conditions: Thermoregulation; Microcirculation; Free Flap

Treatments: Device: Hilotherm Clinic®

Study type: Interventional

Funder types: Other

Identifiers

NCT02466594

KBogenhausen

Details and patient eligibility

About

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.

Full description

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®).

Enrollment: 25 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Hilotherm Clinic®

Other group

Description:

Intervention: 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

Treatment:

Device: Hilotherm Clinic®