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

O

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

67 participants in 2 patient groups

No Tourniquet
No Intervention group
Description:
Patients undergoing hand/wrist surgery without the use of a tourniquet.
Tourniquet
Experimental group
Description:
Patients undergoing hand/wrist surgery with the use of a tourniquet.
Treatment:
Procedure: Tourniquet Use

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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