Impact of Active Thermoregulation on the Microcirculation of Free Flaps

Sponsor

Ulf Dornseifer, MD (Other)

Overall Status

Completed

CT.gov ID

NCT02466594

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Microcirculation Thermoregulation Free Flap	Device: Hilotherm Clinic®	N/A

Detailed 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®).

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Impact of Active Thermoregulation on the Microcirculation of Free Flaps

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	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

Arm

Intervention/Treatment

Other: 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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany	Munich	Bavaria	Germany	81925

Sponsors and Collaborators

Ulf Dornseifer, MD

Investigators

Principal Investigator: Ulf Dornseifer, MD, Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulf Dornseifer, MD, M.D., Klinik Bogenhausen

ClinicalTrials.gov Identifier:

NCT02466594

Other Study ID Numbers:

KBogenhausen

First Posted:

Jun 9, 2015

Last Update Posted:

Jul 7, 2015

Last Verified:

Jul 1, 2015

Study Results

No Results Posted as of Jul 7, 2015