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Liposuction as Treatment for Excessive Axillary Sweat

Primary Purpose

Hyperhidrosis

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Suction-curettage

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Hyperhidrosis, Axillary, Excision, Suction-curettage, Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult individuals with primary axillary hyperhidrosis Exclusion Criteria: Secondary axillary hyperhidrosis Hidrosadenitis axillaris/inguinalis Prior surgery Iontophoresis or botox treatment 12 months prior Known hypersensitivity to local analgetics (lidocaine)

Sites / Locations

Department of Plastic Surgery, Odense University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00228072

First Posted

September 26, 2005

Last Updated

May 28, 2008

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00228072

Brief Title

Liposuction as Treatment for Excessive Axillary Sweat

Official Title

Suction-Curettage vs. Standard Excision in Axillary Hyperhidrosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine if suction-curettage of the axilla is favorable in regard to effect, recovery and cosmetic appearance compared to standard surgical excision of the skin of the axilla in case of excessive sweating.

Detailed Description

The surgical standard treatment for isolated excessive axillary sweating is excision of the hair-bearing area of the axilla. This technique is associated with a risk of impaired wound healing, infections, wide scars and a risk of impairment in the movement of the arm (seldom). A new technique suction-curettage, much alike the liposuction technique, in which the dermis is curettage from a sub-dermal approach with a cutting and sucking devise, may be promising in regard to recovery and cosmetic appearance postoperatively, but the effect of the sweat production is not well known. This study compares liposuction vs. standard excision in individuals with isolated excessive isolated axillary sweating randomized to treatment with one of each technique in both axillas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperhidrosis

Keywords

Hyperhidrosis, Axillary, Excision, Suction-curettage, Outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Suction-curettage

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Finn Gottrup, DMsci

Organizational Affiliation

University Center of Wound Healing, Dept. of Plastic Surgery, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Torben Moeller-Christensen, MD

Organizational Affiliation

Department of Plastic Surgery, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark

Official's Role

Study Director

Facility Information:

Facility Name

Department of Plastic Surgery, Odense University Hospital

City

Odense

State/Province

Fyn

ZIP/Postal Code

DK-5000

Country

Denmark

12. IPD Sharing Statement

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Liposuction as Treatment for Excessive Axillary Sweat

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