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.
|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|
- 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 ]
- 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 ]
|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)|
No Intervention: No Tourniquet
Patients undergoing hand/wrist surgery without the use of a 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
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|Contact: Susan M Odum, MEd 704-323-2265 firstname.lastname@example.org|
|Principal Investigator: Raymond G Gaston, MD|