Postoperative Pain Clinical Trial
Official title:
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial
Verified date | March 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study intends to compare postoperative outcomes of a tissue expander placement
following a mastectomy with two different operative techniques. This study will be
randomized and double blinded comparing the traditional placement of the tissue expander
under an inferolateral serratus muscle flap to a new technique which uses an acellular
dermal matrix as an inferolateral sling, instead of the muscle flap.
The study we are proposing will evaluate the question of whether there is a difference
between the traditional method of serratus flap and the new technique of using an acellular
matrix with tissue expander placement. This will be a double blinded randomized study of
thirty women in each group comparing outcomes which will include postoperative pain,
complications (wound infection, hematoma, capsular contracture, etc), and patient
satisfaction with the procedure.
Status | Terminated |
Enrollment | 36 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study. Exclusion Criteria: - Preoperative radiation therapy - Autoimmune disease - Fever - Uncontrolled diabetes mellitus - Inability to comprehend or cooperate with postoperative instructions - Local or systemic infection - Have any allergies to the excipient ingredients found in the matrix - Pregnancy - Low vascularity of the surrounding tissue - Mechanical trauma - Poor nutrition - Poor general medical condition |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative pain | perioperative up to 1 year | ||
Secondary | aesthetic outcome | 1 year | ||
Secondary | complications (infection, hematoma, capsular contracture) | 1 year | ||
Secondary | Patient satisfaction | 1 year |
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