Use of Dermal Matrix in Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00692692
• Other study ID #: 070416
• Status: Terminated
• Phase: N/A
• First received: June 4, 2008
• Last updated: March 13, 2018
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.

Description:

We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All women who are candidates for breast reconstruction using tissue expanders after mastectomy

Exclusion Criteria:

• Other forms of breast reconstruction after mastectomy

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• DermaMatrix
experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
• standard of care tissue expander breast reconstruction surgery after mastectomy
standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction With the Procedure		one year from time of operation
Primary	Post Surgical Infection	Number of participants with post surgical infection	4 weeks