Tourniquet Use for Lymphedema

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: OrthoCarolina Research Institute, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.

Eligibility Criteria

This trial is for women over 18 who've had a mastectomy with lymph node removal, with or without radiation, and are now facing hand/wrist surgery. They should have tried non-surgical treatments without success and be mentally and physically able to follow the study's procedures. Pregnant women, those on blood thinners that can't be stopped, or anyone needing a tourniquet for more than 20 minutes during surgery cannot participate.

Inclusion Criteria

Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.

You have tried non-surgical treatment for your hand condition, but it did not work. The hand surgery you are going to have will only take less than 20 minutes with a tourniquet.

The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.

Exclusion Criteria

Patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment

Patients under the age of 18

Patients who are pregnant

Participant Groups

The study is testing if using a brachial tourniquet during elective hand surgeries affects postoperative complications in patients with previous breast cancer surgeries. It's an equivalence trial where some will have the tourniquet applied while others won't, randomly assigned.

Group I: Tourniquet Experimental Treatment 1 Intervention

Patients undergoing hand/wrist surgery with the use of a tourniquet.

Group II: No Tourniquet Active Control 1 Intervention

Patients undergoing hand/wrist surgery without the use of a tourniquet.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

OrthoCarolina Charlotte, NC

University of Michigan Medical School Ann Arbor, MI

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc. Lead Sponsor

References