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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02466594
Other study ID # KBogenhausen
Secondary ID
Status Completed
Phase N/A
First received May 25, 2015
Last updated July 5, 2015
Start date November 2013
Est. completion date April 2015

Study information

Verified date July 2015
Source Klinik Bogenhausen
Contact n/a
Is FDA regulated No
Health authority Germany: The Bavarian State Ministry of the Environment and Public Health
Study type Interventional

Clinical Trial Summary

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.


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®).


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 2015
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Germany Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Ulf Dornseifer, MD

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Flow (AU) measured by Doppler flowmetry and remission spectroscopy (Oxygen to See, O2C®, Lea Medizintechnik, Giessen, Germany) Measurements were conducted at the day of the operation No
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