Back to resultsA Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
Primary Purpose
Sweat Gland Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
minimally invasive surgery
Sponsored by
About this trial
This is an interventional treatment trial for Sweat Gland Diseases focused on measuring Axillary osmidrosis, liposuction, minimally invasive surgery
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- unpleasant odor from the axillae
- Willing and able to appear for all scheduled, post-operative visits
Exclusion Criteria:
- under the age of 18
- have undergone a prior surgical intervention
- inappropriate candidates for surgery due to medical or mental health reasons
- elect not to participate in the study
Sites / Locations
- Yuejun Li
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
minimally invasive surgery
Arm Description
There is only one arm to this study. All patients will receive treatment with the minimally invasive surgery for their axillary bromidrosis
Outcomes
Primary Outcome Measures
To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments
the satisfaction of patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01539460
Brief Title
A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
Official Title
A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined.
Detailed Description
Patients with excessive malodor are recruited. They are surgically treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sweat Gland Diseases
Keywords
Axillary osmidrosis, liposuction, minimally invasive surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
minimally invasive surgery
Arm Type
Experimental
Arm Description
There is only one arm to this study. All patients will receive treatment with the minimally invasive surgery for their axillary bromidrosis
Intervention Type
Procedure
Intervention Name(s)
minimally invasive surgery
Intervention Description
Subcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision.
Primary Outcome Measure Information:
Title
To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments
Description
the satisfaction of patients
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
unpleasant odor from the axillae
Willing and able to appear for all scheduled, post-operative visits
Exclusion Criteria:
under the age of 18
have undergone a prior surgical intervention
inappropriate candidates for surgery due to medical or mental health reasons
elect not to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XUEYONG LI, MD
Organizational Affiliation
Department of Plastics and Burns, Tangdu Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yuejun Li
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
12. IPD Sharing Statement
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A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
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