Impact of Active Thermoregulation on the Microcirculation of Free Flaps

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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®).

Conditions

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Microcirculation Thermoregulation Free Flap

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Hilotherm Clinic®

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

Group Type OTHER

Hilotherm Clinic®

Intervention Type 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

Interventions

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Hilotherm Clinic®

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes