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Tourniquet Use for Lymphedema
N/A
Waitlist Available
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Awards & highlights
Study Summary
This trial will compare post-operative complications of hand surgery patients with and without the use of a brachial tourniquet. Patients in the study have previously had a mastectomy with axillary node dissection, with or without radiation treatment or history of lymphedema.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include increased risk of swelling (lymphedema) in the arm due to restricted blood flow from the tourniquet use. Other general surgical risks like infection or pain at the site of operation might occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lymphedema 15% change from pre-post in girth
Secondary outcome measures
Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TourniquetExperimental Treatment1 Intervention
Patients undergoing hand/wrist surgery with the use of a tourniquet.
Group II: No TourniquetActive Control1 Intervention
Patients undergoing hand/wrist surgery without the use of a tourniquet.
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Who is running the clinical trial?
OrthoCarolina Research Institute, Inc.Lead Sponsor
34 Previous Clinical Trials
5,864 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: No Tourniquet
- Group 2: Tourniquet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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