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

This study is currently recruiting participants.
Verified January 2012 by OrthoCarolina Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00984269
First received: September 23, 2009
Last updated: October 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Lymphedema
 Procedure: Tourniquet Use
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Lymphedema 15% change from pre-post in girth [ Time Frame: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 206
Study Start Date: September 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984269

Locations
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.
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00984269     History of Changes
Other Study ID Numbers: 08-09-14B
Study First Received: September 23, 2009
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013