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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984269

Enrollment

Registered

2009-09-25

Start date

2009-08-19

Completion date

2025-12-31

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Brief 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.

Interventions

PROCEDURETourniquet Use

Patients undergoing hand/wrist surgery with or without a tourniquet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Lymphedema 15% change from pre-post in girth	Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026