Liposuction as Treatment for Excessive Axillary Sweat

May 28, 2008 updated by: Odense University Hospital

Suction-Curettage vs. Standard Excision in Axillary Hyperhidrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fyn
      • Odense, Fyn, Denmark, DK-5000
        • Department of Plastic Surgery, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Chair: Finn Gottrup, DMsci, University Center of Wound Healing, Dept. of Plastic Surgery, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark
  • Study Director: Torben Moeller-Christensen, MD, Department of Plastic Surgery, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF20030189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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