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

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ClinicalTrials.gov Identifier: NCT00984269
Recruitment Status : Recruiting
First Posted : September 25, 2009
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphedema Procedure: Tourniquet Use Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial
Study Start Date : September 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
No Intervention: No Tourniquet
Patients undergoing hand/wrist surgery without the use of a tourniquet.
Experimental: Tourniquet
Patients undergoing hand/wrist surgery with the use of a tourniquet.
Procedure: Tourniquet Use
Patients undergoing hand/wrist surgery with or without a tourniquet




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984269


Locations
United States, Michigan
University of Michigan Medical School Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Melissa Shauver    734-232-6171    mshauver@med.umich.edu   
Principal Investigator: Kevin Chung         
United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, MEd    704-323-2265    susan.odum@orthocarolina.com   
Principal Investigator: Raymond G Gaston, MD         
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00984269     History of Changes
Other Study ID Numbers: 08-09-14B
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases