Tourniquet Use for Lymphedema

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using a tourniquet (a device to stop blood flow) during hand surgery affects recovery in individuals who have undergone a mastectomy with lymph node removal. Researchers aim to compare recovery outcomes between those who have surgery with a tourniquet and those who do not. The trial targets individuals who have had breast cancer surgery involving lymph nodes, have not found success with other treatments, and require hand surgery where a tourniquet might be used for less than 20 minutes. The goal is to determine if using a tourniquet influences post-surgery complications. As an unphased trial, this study provides a unique opportunity to enhance understanding of surgical recovery and potentially improve future treatment options.

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.

What prior data suggests that tourniquet use is safe for patients with a history of lymphedema?

Studies have shown that using a tourniquet during hand surgery is generally safe for individuals with a history of lymphedema, which is swelling caused by lymph fluid. Research indicates that a tourniquet does not increase the risk of lymphedema. In fact, one study found no significant difference in patient outcomes whether a tourniquet was used or not. Another study confirmed that using a tourniquet seems safe for planned hand surgeries, even for patients with a history of lymphedema.

However, some individuals reported blood pooling in veins when the tourniquet was applied but not inflated. This does not appear to cause long-term problems, but it is something to be aware of. Overall, evidence suggests that the tourniquet is well-tolerated and does not increase the risk of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of a tourniquet during hand or wrist surgery for patients with lymphedema. Typically, lymphedema treatments focus on managing symptoms with compression garments, exercise, or manual lymph drainage. However, using a tourniquet in surgery could potentially reduce swelling by temporarily restricting blood flow, which might offer a new way to manage fluid buildup during and after surgery. This approach could lead to a better understanding of surgical interventions in managing lymphedema, offering new insights that current non-surgical treatments do not address.

What evidence suggests that tourniquet use is effective for reducing postoperative complications in patients with a history of lymphedema?

This trial will compare the effects of using a tourniquet versus not using one during hand or wrist surgery. Research has shown that using a tourniquet does not increase the risk of lymphedema, which is swelling caused by a buildup of lymph fluid. Studies have found that even if surgeries with a tourniquet take twice as long, the chance of developing lymphedema remains unchanged. Evidence also suggests that using a tourniquet does not cause more complications, even for patients who have had breast surgery or already have lymphedema. Most experts agree that a pneumatic tourniquet is safe for patients with lymphedema. Overall, using a tourniquet in these surgeries is considered safe and does not worsen lymphedema. ^{2 3 4 6 7}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31985641/

Establishing New Recommendations in Lymphedema Tourniquet use was not found to increase rates of lymphedema. Conclusions: Based on the available evidence, there is no increased risk of complications for ...

2. jhandsurg.org jhandsurg.org/article/S0363-5023(16)30285-4/fulltext

Lymphedema Following Elective Hand and Wrist ... Procedures using a tourniquet were on average twice as long as those that were not, yet no difference in the incidence of lymphedema or ...

3. journals.lww.com journals.lww.com/plasreconsurg/Fulltext/2020/02000/An_Evaluation_of_Safety_and_Patient_Outcomes_for.36.aspx?generateEpub=Article%7Cplasreconsurg:2020:02000:00036%7C10.1097/prs.0000000000006438%7C

An Evaluation of Safety and Patient Outcomes for Hand ... Tourniquet use was not found to increase rates of lymphedema. Based on the available evidence, there is no increased risk of complications for elective hand ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1531091405001464

Safety of Upper Extremity Surgery After Prior Treatment for ... Similarly, the majority (74.1%) believed there was no contraindication to the use of a pneumatic tourniquet in patients with lymphedema.26 These studies ...

5. medschool.cuanschutz.edu medschool.cuanschutz.edu/docs/librariesprovider60/research-docs/paton.pdf?sfvrsn=7d7702b9_0

Establishing New Recommendations in Lymphedema Tourniquet use was not found to be associated with an increased rate of complications. Patients with preexisting lymphedema or a history of breast surgery are ...

6. jhandsurg.org jhandsurg.org/article/S0363-5023(15)00728-5/fulltext

Late Onset Upper Extremity Lymphedema Following ... Tourniquet use appears to be safe for elective hand surgery among this patient population. Reference. 1. Habbu, R ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40692915/

Perioperative Arthroscopic Tourniquet Usage However, 76% of participants reported encountering venous congestion when a tourniquet was applied but not inflated. Perioperative tourniquet ...