Breast Augmentation Rehabilitation Program

This study is not yet open for participant recruitment.
Verified May 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01857765
First received: May 9, 2013
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.


Condition Intervention
Breast Implants
Surgery, Plastic
Behavioral: Rehabilitation
Behavioral: Follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Time to return to baseline as measured on Visual Analogue Scale for pain [ Time Frame: Baseline, six months, and one year after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to return to bilateral shoulder baseline range of motion [ Time Frame: Baseline, six months, and one year after surgery ] [ Designated as safety issue: No ]
  • Change in psychosocial outcomes as measured by the BREAST-Q questionnaire [ Time Frame: Baseline, six months, and one year after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care Behavioral: Follow-up
Follow-up with surgeon's clinic
Experimental: Rehabilitation Behavioral: Rehabilitation
Range of motion stretching exercises
Behavioral: Follow-up
Follow-up with surgeon's clinic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women who undergo endoscopic transaxillary subpectoral breast augmentation
  • women above the age of 18 years
  • women with a BMI 18-27

Exclusion Criteria:

  • women who underwent previous breast reconstruction (cosmetic or therapeutic)
  • women who underwent previous chest surgery
  • women with previous chest trauma
  • women who underwent previous shoulder/arm surgery
  • women with previous shoulder/arm injury
  • women who smoke
  • women who are Immunocompromised
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857765

Contacts
Contact: Erin Brown, MD 604-875-5866 erin.brown@vch.ca

Locations
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Erin Brown, MD    604-875-5866    erin.brown@vch.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Erin Brown, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01857765     History of Changes
Other Study ID Numbers: H11-02077
Study First Received: May 9, 2013
Last Updated: May 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
rehabilitation
reconstructive surgery

ClinicalTrials.gov processed this record on April 15, 2014