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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00984269
• Other study ID #: 08-09-14B
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 19, 2009
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: December 2024
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Procedure:
• Tourniquet Use
Patients undergoing hand/wrist surgery with or without a tourniquet

Locations

Country	Name	City	State
United States	University of Michigan Medical School	Ann Arbor	Michigan
United States	OrthoCarolina	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphedema 15% change from pre-post in girth		Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Secondary	Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications		10-14 days, 6 weeks, 3 months, 6 months, and 1 year