Modified Suction-assisted Cartilage Shaver for Axillary Osmidrosis

NCT03793374 | Unknown

• 1 other identifier: 201801926B0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study included patients who suffered from moderate to severe axillary osmidrosis to receive the modified suction-assisted cartilage shaver, and evaluated the efficacy and complications.

Conditions

Treatment Outcome; Axillary Odor, Variation in

Keywords

Axillary osmidrosis; Surgery; Cartilage shaver

Outcome Measures

Primary Outcomes (1)

• The change of malodor of axillary osmidorsis after the modified suction-assiated cartilage shaver

  The efficacy of surgical treatment for axillary osmidrosis is evaluated by the change of the malodor. The degree of malodor is subjective, therefore, the investigators classified the degree of malodor from 1 to 5 to indicate the least severe to the most sever condition. The degree of malodor was recorded before the operation, 1 month after the operation, and 1 year after the operation. The investigators evaluate the efficacy of the surgical treatment by the changes of the degree of the malodor of axillary osmidrosis.

  The treatment efficacy is evaluated 1 year after the surgery.

Secondary Outcomes (1)

• The rate of complications of the modified suction-assiated cartilage shaver for axillary osmidrosis

  The immediate and longterm complications are recorded and evaluated at 1 week and 1 year respectively after the surgery.

Study Arms (1)

Axillary osmidrosis patients

Patients with axillary malodor and require surgical intervention. The subcutaneous apocrine glands shaving were used.

Other: Subcutaneous apocrine glands shaving

Interventions

Subcutaneous apocrine glands shaving OTHER

A 0.5-cm long incision was made in the identified elliptical surgical area at each axilla for the access of arthroscopy to remove the apocrine glands. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo, Florida, USA) was introduced through the incisions to remove of the subcutaneous apocrine glands radially. After defatting, the incisions were closed primarily with 4-0 polyglactin. We anchored the defatting skin to the axillary fascia by 4-0 nylon sutures instead of the tie-over dressing or tissue glues, and we also made several drainage holes by inserting an 18G needle obliquely into the defatting skin. Therefore, draining tubes were no longer needed. We will remove the stiches at the 8th day after the operation.

Axillary osmidrosis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with axillary osmidrosis and require surgical intervention.

You may qualify if:

• Patients with moderate to severe axillary osmidrosis and require surgical intervention.

You may not qualify if:

• Patients with bleeding tendency were excluded.
• Patients with active infections.
• Patients with major cardiovascular diseases.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Related Publications (5)

• Yoshikata R, Yanai A, Takei T, Shionome H. Surgical treatment of axillary osmidrosis. Br J Plast Surg. 1990 Jul;43(4):483-5. doi: 10.1016/0007-1226(90)90019-v. No abstract available.

  PMID: 2393776 BACKGROUND

• Wu WH. Ablation of apocrine glands with the use of a suction-assisted cartilage shaver for treatment of axillary osmidrosis: an analysis of 156 cases. Ann Plast Surg. 2009 Mar;62(3):278-83. doi: 10.1097/SAP.0b013e3181776398.

  PMID: 19240525 BACKGROUND

• Chern E, Yau D, Chuang FC, Wu WM. Arthroscopic shaver with refinement for axillary osmidrosis. Int J Dermatol. 2010 Jul;49(7):813-7. doi: 10.1111/j.1365-4632.2010.04540.x.

  PMID: 20618505 BACKGROUND

• Lee JC, Kuo HW, Chen CH, Juan WH, Hong HS, Yang CH. Treatment for axillary osmidrosis with suction-assisted cartilage shaver. Br J Plast Surg. 2005 Mar;58(2):223-7. doi: 10.1016/j.bjps.2004.07.002.

  PMID: 15710118 BACKGROUND

• Tseng YJ, Lee CH, Lin SH. Modified Suction-Assisted Cartilage Shaver for Axillary Osmidrosis. Biomed Res Int. 2019 May 8;2019:7314753. doi: 10.1155/2019/7314753. eCollection 2019.

  PMID: 31205944 DERIVED

Study Officials

• Shang-Hung Lin, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Ju Tseng, M.D.

CONTACT

+886961123176; yuju311@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of the Department of Dermatology of Kaohsiung Chang Gung Memorial Hospital

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 4, 2019
• Study Start: December 12, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)