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CompletedNCT01235286RIPCUpdated Nov 5, 2010

Cutaneous Remote Ischemic Preconditioning in Plastic Surgery

An interventional study of remote ischemic preconditioning in Ischemic Preconditioning, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-05.

Sponsored by Hannover Medical School · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Ischemic Preconditioning

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Keywords

  • remote ischemic preconditioning, free flap, microcirculation
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In context

Ischemia

2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.

This study's enrollment of 27 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.

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Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy male and female subjects aged 18 to 35 years

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    remote ischemic preconditioning

    Procedure: remote ischemic preconditioning

Interventions

  • Procedureremote 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.

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What researchers measure

Primary outcomes

  1. Change in microcirculation

    * capillary blood flow \[arbitrary units AU\] * capillary blood velocity \[AU\] * tissue oxygen saturation \[%\] * relative postcapillary venous filling pressure \[AU\]

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Study locations

1 site
  • Medical School Hannover
    Hannover, 30625, Germany
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References and documents

Publications

  • Kraemer R, Lorenzen J, Kabbani M, Herold C, Busche M, Vogt PM, Knobloch K. Acute effects of remote ischemic preconditioning on cutaneous microcirculation--a controlled prospective cohort study. BMC Surg. 2011 Nov 23;11:32. doi: 10.1186/1471-2482-11-32. PubMed 22111972 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01235286
Lead sponsor
Hannover Medical School
First posted
Nov 5, 2010
Start date
Sep 2010
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Nov 5, 2010

Study contacts

Robert Kraemer, MD
principal investigator · Medical School Hannover, Plastic, Hand and Reconstructive Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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