Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial
1 other identifier
interventional
67
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2009
CompletedFirst Submitted
Initial submission to the registry
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 28, 2025
April 1, 2025
11 years
September 23, 2009
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Lymphedema 15% change from pre-post in girth
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
10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Study Arms (2)
No Tourniquet
NO INTERVENTIONPatients undergoing hand/wrist surgery without the use of a tourniquet.
Tourniquet
EXPERIMENTALPatients undergoing hand/wrist surgery with the use of a tourniquet.
Interventions
Patients undergoing hand/wrist surgery with or without a tourniquet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Michigan Medical School
Ann Arbor, Michigan, 48109, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2009
First Posted
September 25, 2009
Study Start
August 19, 2009
Primary Completion
August 20, 2020
Study Completion
December 1, 2025
Last Updated
April 28, 2025
Record last verified: 2025-04