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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
OrthoCarolina Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 23, 2009
Last Updated
February 8, 2023
Sponsor
OrthoCarolina Research Institute, Inc.
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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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