The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00616824
• Other study ID #: 070415
• Secondary ID: 070415
• Status: Terminated
• Phase: Phase 4
• First received: February 5, 2008
• Last updated: March 30, 2017
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Complications
• Mastectomy
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Dermamatrix to cover lateral aspect of tissue expander
Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
• Serratus anterior to cover lateral aspect of tissue expander
Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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