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

OrthoCarolina Research Institute, Inc.

Status

Active, not recruiting

Conditions

Lymphedema

Treatments

Procedure: Tourniquet Use

Study type

Interventional

Funder types

Other

Identifiers

NCT00984269

08-09-14B

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.