Impact of Active Thermoregulation on the Microcirculation of Free Flaps

Microcirculation Clinical Trial

Official title:

Impact of Active Thermoregulation on the Microcirculation of Free Flaps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466594
• Other study ID #: KBogenhausen
• 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

• Free Flap
• Microcirculation
• Thermoregulation

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