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

This study is currently recruiting participants.
Verified January 2014 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: January 14, 2014
Last verified: January 2014

September 23, 2009
January 14, 2014
September 2009
October 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00984269 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphedema
Procedure: Tourniquet Use
Patients undergoing hand/wrist surgery with or without a tourniquet
  • 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.
    Intervention: Procedure: Tourniquet Use
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
206
October 2016
October 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Not Provided
United States
 
NCT00984269
08-09-14B
Yes
OrthoCarolina Research Institute, Inc.
OrthoCarolina Research Institute, Inc.
Not Provided
Not Provided
OrthoCarolina Research Institute, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP