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

Not Applicable

Active, not recruiting

• Conditions: Lymphedema
• Interventions: Procedure: Tourniquet Use

• Registration Number: NCT00984269
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-19
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2020-08-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 67

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tourniquet	Tourniquet Use	Patients undergoing hand/wrist surgery with the use of a tourniquet.

Primary Outcome Measures

Name	Time	Method
Lymphedema 15% change from pre-post in girth	Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year

Secondary Outcome Measures

Name	Time	Method
Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications	10-14 days, 6 weeks, 3 months, 6 months, and 1 year

Trial Locations

Locations (2)

University of Michigan Medical School; 🇺🇸 Ann Arbor, Michigan, United States

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States