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A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
YUEJUN LI, Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT01539460
First received: February 21, 2012
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Sweat Gland Diseases
 Procedure: minimally invasive surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision

Resource links provided by NLM:

MedlinePlus related topics: Sweat
U.S. FDA Resources

Further study details as provided by Tang-Du Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Procedure: minimally invasive surgery
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539460

Locations
China, Shaanxi
Yuejun Li
Xi'an, Shaanxi, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
Investigators
Study Director: XUEYONG LI, MD Department of Plastics and Burns, Tangdu Hospital
  More Information

No publications provided

Responsible Party: YUEJUN LI, associate professor, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01539460     History of Changes
Other Study ID Numbers: TDH0369
Study First Received: February 21, 2012
Last Updated: February 24, 2012
Health Authority: China: Ministry of Health

Keywords provided by Tang-Du Hospital:
Axillary osmidrosis
liposuction
minimally invasive surgery

Additional relevant MeSH terms:
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013