Cutaneous Remote Ischemic Preconditioning in Plastic Surgery (RIPC)

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01235286
First received: November 4, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

Background: In plastic and reconstructive surgery, free flaps are routinely used for treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap necrosis by conditioning tissue tolerance against ischemia. Although previous studies indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on a potential free flap location in a human in-vivo setting for the first time.

Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation, arterial capillary blood flow and postcapillary venous flow in a remote free flap donor location. To what extent remote preconditioning might ameliorate the reperfusion injury of free flap transplantation, further clinical trials have to evaluate both in the means of microcirculatory assessment and partial or total flap loss as end points of these studies.


Condition Intervention
Ischemic Preconditioning
Procedure: remote ischemic preconditioning

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Anterolateral Thigh Flaps

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Change in microcirculation [ Designated as safety issue: No ]
    • capillary blood flow [arbitrary units AU]
    • capillary blood velocity [AU]
    • tissue oxygen saturation [%]
    • relative postcapillary venous filling pressure [AU]


Enrollment: 27
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: remote ischemic preconditioning Procedure: remote ischemic preconditioning

A standardized location for microcirculatory assessment was determined on the left leg of each participant between the proximal and distal third of a drawn line between the anterior superior iliac spine and the lateral aspect of the Patella.

The healthy subjects had to rest before starting data assessment in a horizontal position for 15 minutes. The probe was taped on the left upper leg in a standardized manner after localizing the measuring point. A blood pressure cuff was applied on the contralateral upper arm. Baseline data was assessed over 5 minutes before starting remote ischemia. Three circles of a five minute ischemia were applied at the contralateral right upper arm at suprasystolic levels. Parameters of microcirculation were assessed continuously over time. Microcirculation during the reperfusion phase was ascertained over 10 minutes after first and second remote ischemia and 15 minutes after the third remote ischemia.


  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male and female subjects aged 18 to 35 years

Exclusion Criteria:

  • soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235286

Locations
Germany
Medical School Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Robert Kraemer, MD Medical School Hannover, Plastic, Hand and Reconstructive Surgery
  More Information

No publications provided by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Kraemer, Hannover Medical School, Plastic, Hand and Reconstructive Surgery
ClinicalTrials.gov Identifier: NCT01235286     History of Changes
Other Study ID Numbers: Kraemer001
Study First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
remote ischemic preconditioning, free flap, microcirculation

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014