Breast Augmentation Rehabilitation Program

This study has been withdrawn prior to enrollment.

(The resident in charge of the project has graduated so we decided to close this study)

Sponsor:

Information provided by (Responsible Party):

University of British Columbia

ClinicalTrials.gov Identifier:

NCT01857765

First received: May 9, 2013

Last updated: October 10, 2014

Last verified: October 2014

History of Changes

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:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

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 ]


Enrollment:	0
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857765

Locations


Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada

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:	October 10, 2014
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:


rehabilitation reconstructive surgery

ClinicalTrials.gov processed this record on March 03, 2015

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