Treatment OutcomeNCT03793374
Modified Suction-assisted Cartilage Shaver for Axillary Osmidrosis
An observational study of Treatment Outcome and Axillary Odor, Variation in, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Treatment Outcome, Axillary Odor, Variation in
- What is being tested?
- Subcutaneous apocrine glands shaving
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with axillary osmidrosis and require surgical intervention.
Who may be able to join
- Patients with moderate to severe axillary osmidrosis and require surgical intervention.
Who cannot join
- Patients with bleeding tendency were excluded.
- Patients with active infections.
- Patients with major cardiovascular diseases.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Kaohsiung City, 83301
Yu-Ju Tseng, M.D., +886961123176, yuju311@gmail.com
About this study
Official title: The Efficacy of Modified Suction-assisted Cartilage Shaver for Axillary Osmidrosis
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.
Read the detailed description
<Patients> After obtaining the agreement of Chang Gung Medical Foundation Institutional Review Board, the investigators retrospectively included patients from July 2013 to September 2017. There were 39 patients treated for AO by the same dermatologist with suction-assisted cartilage shaver at the Department of Dermatology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan. There were 28 females and 11 males, ranging from 14 to 52 years of age. The participants were all bothered by the axillary osmidrosis, which had a huge impact on their daily life with the embarrassing malodors. Operations were performed under local anaesthesia and in an outpatient basis.
<Operation> During the procedure, both of patient's axillae were exposed with the patient lying supine and arms abducted to avoid injury to the brachial plexus. The investigator cut the axillary hair short for better visualizing the region of apocrine glands, which are located near the hair follicles. The hair bearing elliptical region of axilla was marked before hair cutting. Tumescent solution was prepared with 0.1% lidocaine, 1:500,000 epinephrine and 10mEq/L sodium bicarbonate. The investigator injected the tumescent solution to the subcutaneous level of each axilla in view of the hydro-dissection ability of tumescent and minimizing the bleeding.
A 0.5-cm long incision was made in the center of identified elliptical surgical area at each axilla for the better access of arthroscopy to remove the apocrine glands located at dermo-subcutaneous junction, and for hiding the scar in the skin crease to make it less noticeable. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo, Florida, USA) was introduced through the incisions to remove of the subcutaneous tissue containing the apocrine glands radially. The investigator set the system to keep the inner cannula at 1500 rotations per minute in oscillation mode. After defatting, the incisions were closed primarily with 4-0 polyglactin. The investigator anchored the defatting skin to the axillary fascia by using 4-0 nylon sutures instead of the tie-over dressing used in the conventional shaver procedure, and the investigator also made several drainage holes by inserting an 18G needle obliquely into the defatting skin rather than placing the drainage tubes used in the conventional shaver procedure. Therefore, draining tubes were no longer needed. The investigator will remove the stitches at the 8th day after the operation.
<Efficacy assessments> The participants' medical history, physical examinations, and vital signs were carefully collected before the operation. The investigators retrospectively evaluated the pre- and post-operative clinical efficacies with a patient-centered scoring method. The severity of AO before the operation was classified from 1 to 5 to indicate the least severe to the most severe condition, from undetectable, mild, moderate, severe, to unbearable of malodor. The clinical efficacy was classified to 5 grades: poor (0%-20%), fair (21%-39%), acceptable (40%- 59%), good(60%-79%), and excellent (80%-100%), which was evaluated based on the elimination of malodor and the post-operative satisfaction. To evaluate the safety, adverse reactions such as hematoma, seroma, infection, wound necrosis, skin necrosis or perforation, and scar formation were recorded.
- Conditions
- Treatment Outcome, Axillary Odor, Variation in
- Being tested
- Subcutaneous apocrine glands shaving
- Keywords
- Axillary osmidrosis, Surgery, Cartilage shaver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous apocrine glands shavingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Axillary osmidrosis patients | Patients with axillary malodor and require surgical intervention. The subcutaneous apocrine glands shaving were used. Receives: Other: Subcutaneous apocrine glands shaving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To evaluate the safety of the modified surgical method, adverse reactions such as hematoma, seroma, infection, wound necrosis, skin necrosis or perforation, and scar formation were recorded and evaluated.
Measured: The immediate and longterm complications are recorded and evaluated at 1 week and 1 year respectively after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start12 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Treatment OutcomeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shang-Hung Lin, Chang Gung Memorial Hospital
- Investigators
- Shang-Hung Lin, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793374
- Sponsor's protocol ID
- 201801926B0
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2393776Wu 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.
PubMed 19240525Chern 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.
PubMed 20618505Lee 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.
PubMed 15710118Tseng 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.
PubMed 31205944
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Modified Suction-assisted Cartilage Shaver for Axillary Osmidrosis
- ClinicalTrials.gov ID
- NCT03793374
- Acronym / sponsor ID
- 201801926B0
- Conditions
- Treatment Outcome, Axillary Odor, Variation in
- Keywords
- Axillary osmidrosis, Surgery, Cartilage shaver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
<Patients> After obtaining the agreement of Chang Gung Medical Foundation Institutional Review Board, the investigators retrospectively included patients from July 2013 to September 2017. There were 39 patients treated for AO by the same dermatologist with suction-assisted cartilage shaver at the Department of Dermatology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan. There were 28 females and 11 males, ranging from 14 to 52 years of age. The participants were all bothered by the axillary osmidrosis, which had a huge impact on their daily life with the embarrassing malodors. Operations were performed under local anaesthesia and in an outpatient basis.
<Operation> During the procedure, both of patient's axillae were exposed with the patient lying supine and arms abducted to avoid injury to the brachial plexus. The investigator cut the axillary hair short for better visualizing the region of apocrine glands, which are located near the hair follicles. The hair bearing elliptical region of axilla was marked before hair cutting. Tumescent solution was prepared with 0.1% lidocaine, 1:500,000 epinephrine and 10mEq/L sodium bicarbonate. The investigator injected the tumescent solution to the subcutaneous level of each axilla in view of the hydro-dissection ability of tumescent and minimizing the bleeding.
A 0.5-cm long incision was made in the center of identified elliptical surgical area at each axilla for the better access of arthroscopy to remove the apocrine glands located at dermo-subcutaneous junction, and for hiding the scar in the skin crease to make it less noticeable. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo, Florida, USA) was introduced through the incisions to remove of the subcutaneous tissue containing the apocrine glands radially. The investigator set the system to keep the inner cannula at 1500 rotations per minute in oscillation mode. After defatting, the incisions were closed primarily with 4-0 polyglactin. The investigator anchored the defatting skin to the axillary fascia by using 4-0 nylon sutures instead of the tie-over dressing used in the conventional shaver procedure, and the investigator also made several drainage holes by inserting an 18G needle obliquely into the defatting skin rather than placing the drainage tubes used in the conventional shaver procedure. Therefore, draining tubes were no longer needed. The investigator will remove the stitches at the 8th day after the operation.
<Efficacy assessments> The participants' medical history, physical examinations, and vital signs were carefully collected before the operation. The investigators retrospectively evaluated the pre- and post-operative clinical efficacies with a patient-centered scoring method. The severity of AO before the operation was classified from 1 to 5 to indicate the least severe to the most severe condition, from undetectable, mild, moderate, severe, to unbearable of malodor. The clinical efficacy was classified to 5 grades: poor (0%-20%), fair (21%-39%), acceptable (40%- 59%), good(60%-79%), and excellent (80%-100%), which was evaluated based on the elimination of malodor and the post-operative satisfaction. To evaluate the safety, adverse reactions such as hematoma, seroma, infection, wound necrosis, skin necrosis or perforation, and scar formation were recorded.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axillary osmidrosis patients | – | Other: Subcutaneous apocrine glands shavingPatients with axillary malodor and require surgical intervention. The subcutaneous apocrine glands shaving were used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with axillary osmidrosis and require surgical intervention.
Key inclusion criteria (1 listed)
- Patients with moderate to severe axillary osmidrosis and require surgical intervention.
Key exclusion criteria (3 listed)
- Patients with bleeding tendency were excluded.
- Patients with active infections.
- Patients with major cardiovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous apocrine glands shavingA 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. | Other | Axillary osmidrosis patients |
Primary outcome
The change of malodor of axillary osmidorsis after the modified suction-assiated cartilage shaver
Time frame: The treatment efficacy is evaluated 1 year after the surgery.
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.
1 secondary outcome
The rate of complications of the modified suction-assiated cartilage shaver for axillary osmidrosis
Time frame: The immediate and longterm complications are recorded and evaluated at 1 week and 1 year respectively after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Background: PubMed 2393776Yoshikata 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.
- Background: PubMed 19240525Wu 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.
- Background: PubMed 20618505Chern 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.
- Background: PubMed 15710118Lee 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.
- Derived from this study: PubMed 31205944Tseng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shang-Hung Lin, M.D. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Outcome and Axillary Odor, Variation in, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ju Tseng, M.D. (+886961123176, yuju311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of malodor of axillary osmidorsis after the modified suction-assiated cartilage shaver (time frame: The treatment efficacy is evaluated 1 year after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793374, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.