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

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ClinicalTrials.gov Identifier: NCT01539460
Recruitment Status : Enrolling by invitation
First Posted : February 27, 2012
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
YUEJUN LI, Tang-Du Hospital

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.

Condition or disease Intervention/treatment Phase
Sweat Gland Diseases Procedure: minimally invasive surgery Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2012
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat
U.S. FDA Resources

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
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: YUEJUN LI, associate professor, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01539460     History of Changes
Other Study ID Numbers: TDH0369
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Sweat Gland Diseases
Skin Diseases