Lymphedema Following Hand/Wrist Surgery in Women Post Axi... | NCT00984269

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

NCT00984269

Sponsor

OrthoCarolina Research Institute, Inc.

Status

Active, not recruiting

Last Update Posted

Apr 28, 2025Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Lymphedema

Interventions

Tourniquet Use

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2009Actual

Primary Completion Date

Aug 20, 2020Actual

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 23, 2009

First Submission Date that Met QC Criteria

Sep 24, 2009

First Posted Date

Sep 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2025

Last Update Posted Date

Apr 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tourniquet Use	Procedure	Patients undergoing hand/wrist surgery with or without a tourniquet	Tourniquet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Medical School		Ann Arbor	Michigan	48109	United States
OrthoCarolina

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases