- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235286
Cutaneous Remote Ischemic Preconditioning in Plastic Surgery (RIPC)
Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Anterolateral Thigh Flaps
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hannover, Germany, 30625
- Medical School Hannover
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Change in microcirculation
|
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Kraemer, MD, Medical School Hannover, Plastic, Hand and Reconstructive Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kraemer001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Preconditioning
-
The Hospital for Sick ChildrenUnknownIschemic PreconditioningCanada
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruitingIschemic PreconditioningChina
-
Yi YangCompletedIschemic PreconditioningChina
-
University of AarhusUnknown
-
Xuzhou Medical UniversityCompletedMyocardial Injury | Remote Ischemic PreconditioningChina
-
Seoul National University HospitalCompletedRemote Ischemic PreconditioningKorea, Republic of
-
University of GuelphCompletedDietary Exposure | Ischemic PreconditioningCanada
-
University of AlbertaCompletedRemote Ischemic Preconditioning | Myocardial ProtectionCanada
-
University of Texas Southwestern Medical CenterAstraZenecaTerminatedIschemic PreconditioningUnited States
-
Sun Yat-sen UniversityCompletedIschemic PreconditioningChina
Clinical Trials on remote ischemic preconditioning
-
Tartu University HospitalCompletedAtherosclerosis | Stable Angina | Peripheral Artery Disease | Contrast-induced NephropathyEstonia
-
St. Francis Hospital, New YorkTerminatedCoronary Artery DiseaseUnited States
-
Capital Medical UniversityPeking University First HospitalCompletedCerebral Small Vessel DiseaseChina
-
Azienda Ospedaliera Città della Salute e della...CompletedAcute Kidney InjurySpain, France, Italy
-
Medical University of LodzCompletedRemote Ischemic Preconditioning | Contrast Induced - Acute Kidney InjuryPoland
-
Ulsan University HospitalCompletedContrast Induced Acute Kidney InjuryKorea, Republic of
-
Università Vita-Salute San RaffaeleRecruitingMyocardial Ischemia | SurgeryItaly, Russian Federation, Serbia
-
Institut für Pharmakologie und Präventive MedizinWithdrawnEffectivity of RIPC in Outcomes of TAVI ProcedureGermany
-
Xijing HospitalUnknownCardiac Surgery PatientsChina