NCT01539460

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

5.8 years

First QC Date

February 21, 2012

Last Update Submit

May 11, 2017

Conditions

Sweat Gland Diseases

Keywords

Axillary osmidrosisliposuctionminimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 24 months

Study Arms (1)

minimally invasive surgery

EXPERIMENTAL

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

Interventions

minimally invasive surgeryPROCEDURE

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.

minimally invasive surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years or older
  • unpleasant odor from the axillae
  • Willing and able to appear for all scheduled, post-operative visits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuejun Li

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Sweat Gland Diseases

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • XUEYONG LI, MD

    Department of Plastics and Burns, Tangdu Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

CN(1)