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

NCT ID: NCT00984269

Last Updated: 2025-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-19

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Tourniquet

Patients undergoing hand/wrist surgery without the use of a tourniquet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Tourniquet

Patients undergoing hand/wrist surgery with the use of a tourniquet.

Group Type EXPERIMENTAL

Tourniquet Use

Intervention Type PROCEDURE

Patients undergoing hand/wrist surgery with or without a tourniquet

Interventions

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Tourniquet Use

Patients undergoing hand/wrist surgery with or without a tourniquet

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Michigan Medical School

Ann Arbor, Michigan, United States

Site Status

OrthoCarolina

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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08-09-14B

Identifier Type: -

Identifier Source: org_study_id

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