- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539460
A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
May 11, 2017 updated by: YUEJUN LI, Tang-Du Hospital
A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710038
- Yuejun Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: minimally invasive surgery
There is only one arm to this study.
All patients will receive treatment with the minimally invasive surgery for their axillary bromidrosis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments
Time Frame: up to 24 months
|
the satisfaction of patients
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: XUEYONG LI, MD, Department of Plastics and Burns, Tangdu Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (ANTICIPATED)
November 1, 2017
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
February 21, 2012
First Submitted That Met QC Criteria
February 24, 2012
First Posted (ESTIMATE)
February 27, 2012
Study Record Updates
Last Update Posted (ACTUAL)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDH0369
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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