67 Participants Needed

Tourniquet Use for Lymphedema

Recruiting at 1 trial location
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: OrthoCarolina Research Institute, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

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.
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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
See 3 more

Timeline

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

Treatment Details

Interventions

  • Tourniquet Use
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials
37
Recruited
6,000+

References

Use of a tourniquet with and without adrenaline reduces blood loss during liposuction for lymphoedema of the arm. [2022]
Upper Extremity Subcutaneous Lymphatic Drainage "Lymphocentesis" for Symptom Relief in End-Stage Breast Cancer. [2019]
[Postmastectomy lymphedema and carpal tunnel syndrome. Surgical considerations and advice for patients]. [2006]
Creation of a Rat Lower Limb Lymphedema Model. [2021]
[Lymphedema: is there a treatment?]. [2019]