LymphedemaNCT00984269
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
A study testing Tourniquet Use in people with Lymphedema, run by OrthoCarolina Research Institute, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Tourniquet Use
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2009to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.
- Patients ages 18 and over
- Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of < 20 minutes.
- The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.
Who cannot join
- 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
- Patients presenting for an elective hand procedure with an anticipated tourniquet time of > 20 minutes.
- Patients who are on a blood thinner which cannot be stopped prior to surgery
- The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Medical School
Ann Arbor, Michigan, 48109
OrthoCarolina
Charlotte, North Carolina, 28207
About this study
Official title: Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical 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.
- Conditions
- Lymphedema
- Being tested
- Tourniquet Use
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet UseProcedure or surgery
Patients undergoing hand/wrist surgery with or without a tourniquet
| Study group | Role | What they receive |
|---|---|---|
| No Tourniquet | No intervention | Patients undergoing hand/wrist surgery without the use of a tourniquet. |
| Tourniquet | Experimental | Patients undergoing hand/wrist surgery with the use of a tourniquet. Receives: Procedure: Tourniquet Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema 15% change from pre-post in girth
Measured: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Secondary outcomes (1)
Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications
Measured: 10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study start19 Aug 2009
- Primary completion20 Aug 2020
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984269
- Sponsor's protocol ID
- 08-09-14B
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2009
- Last updated
- 28 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT00984269
- Acronym / sponsor ID
- 08-09-14B
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 19 Aug 2009 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Tourniquet | No intervention | –Patients undergoing hand/wrist surgery without the use of a tourniquet. |
| Tourniquet | Experimental | Procedure: Tourniquet UsePatients undergoing hand/wrist surgery with the use of a tourniquet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.
- Patients ages 18 and over
- Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of < 20 minutes.
- The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.
Key exclusion criteria (6 listed)
- 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
- Patients presenting for an elective hand procedure with an anticipated tourniquet time of > 20 minutes.
- Patients who are on a blood thinner which cannot be stopped prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tourniquet UsePatients undergoing hand/wrist surgery with or without a tourniquet | Procedure or surgery | Tourniquet |
Primary outcome
Lymphedema 15% change from pre-post in girth
Time frame: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year
1 secondary outcome
Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications
Time frame: 10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet Use in people with Lymphedema, run by OrthoCarolina Research Institute, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema 15% change from pre-post in girth (time frame: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2025.