Status:
ACTIVE_NOT_RECRUITING
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Conditions:
Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00984269
Start Date
August 19 2009
End Date
December 1 2025
Last Update
April 28 2025
Active Locations (2)
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1
University of Michigan Medical School
Ann Arbor, Michigan, United States, 48109
2
OrthoCarolina
Charlotte, North Carolina, United States, 28207