Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2017
Start Date:September 2009
End Date:December 2018

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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.


Inclusion Criteria:

- 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 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

- 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.
We found this trial at
2
sites
Ann Arbor, Michigan 48109
Principal Investigator: Kevin Chung
Phone: 734-232-6171
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Charlotte, North Carolina 28207
Principal Investigator: Raymond G Gaston, MD
Phone: 704-323-2265
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Charlotte, NC
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