Tourniquet Use for Lymphedema

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Under 18, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

67 Participants Needed

What You Need to Know Before You Apply

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. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo hand/wrist surgery with or without the use of a tourniquet

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative complications following surgery

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tourniquet Use

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Use of a tourniquet with and without adrenaline reduces blood loss during liposuction for lymphoedema of the arm. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Upper Extremity Subcutaneous Lymphatic Drainage "Lymphocentesis" for Symptom Relief in End-Stage Breast Cancer. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Postmastectomy lymphedema and carpal tunnel syndrome. Surgical considerations and advice for patients]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Creation of a Rat Lower Limb Lymphedema Model. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Lymphedema: is there a treatment?]. [2019]