Tourniquet Use for Lymphedema
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.
Do I need to stop taking my current medications for the trial?
The trial requires that you stop taking blood thinners before surgery. For other medications, the protocol does not specify, so it's best to discuss with the trial team.
How does tourniquet use differ from other treatments for lymphedema?
The use of a tourniquet in treating lymphedema is unique because it helps reduce blood loss during procedures like liposuction, which is not a common approach in standard lymphedema treatments. This method is particularly beneficial in minimizing the need for blood transfusions, especially when combined with techniques like tumescence.12345
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo hand/wrist surgery with or without the use of a tourniquet
Postoperative Monitoring
Participants are monitored for postoperative complications following surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Tourniquet Use
Find a Clinic Near You
Who Is Running the Clinical Trial?
OrthoCarolina Research Institute, Inc.
Lead Sponsor