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Active, Not Recruiting

NCT Number: NCT00984269

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Medical School, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tourniquet Use

Procedure

Patients undergoing hand/wrist surgery with or without a tourniquet

Primary outcomes

  1. Lymphedema 15% change from pre-post in girth

    Time frame: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial

Important dates

Study start
2009
Primary completion
2020
Study completion
2025
First posted
Sep 25, 2009
Registry last updated
Apr 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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