Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Primary Purpose
Lymphedema
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tourniquet Use
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
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.
Sites / Locations
- University of Michigan Medical School
- OrthoCarolina
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Tourniquet
Tourniquet
Arm Description
Patients undergoing hand/wrist surgery without the use of a tourniquet.
Patients undergoing hand/wrist surgery with the use of a tourniquet.
Outcomes
Primary Outcome Measures
Lymphedema 15% change from pre-post in girth
Secondary Outcome Measures
Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications
Full Information
NCT ID
NCT00984269
First Posted
September 23, 2009
Last Updated
February 8, 2023
Sponsor
OrthoCarolina Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00984269
Brief Title
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Official Title
Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2009 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoCarolina Research Institute, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Tourniquet
Arm Type
No Intervention
Arm Description
Patients undergoing hand/wrist surgery without the use of a tourniquet.
Arm Title
Tourniquet
Arm Type
Experimental
Arm Description
Patients undergoing hand/wrist surgery with the use of a tourniquet.
Intervention Type
Procedure
Intervention Name(s)
Tourniquet Use
Intervention Description
Patients undergoing hand/wrist surgery with or without a tourniquet
Primary Outcome Measure Information:
Title
Lymphedema 15% change from pre-post in girth
Time Frame
Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Michigan Medical School
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
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