NCT02466594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

May 25, 2015

Last Update Submit

July 5, 2015

Conditions

MicrocirculationThermoregulationFree Flap

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hilotherm Clinic®

OTHER

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®

Interventions

Hilotherm Clinic®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

Hilotherm Clinic®

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients receiving free perforator flaps with a skin island not less than 4x4 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany

Munich, Bavaria, 81925, Germany

Location

Study Officials

  • Ulf Dornseifer, MD

    Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 25, 2015

First Posted

June 9, 2015

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

DE(1)