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

NCT00616824 | Terminated Phase 4 DMC

• 1 other identifier: 070415
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mastectomy; Postoperative Pain; Complications

Keywords

Acellular dermal matrix; breast reconstruction; tissue expander; postoperative pain; complication; pain; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  perioperative up to 1 year

Secondary Outcomes (3)

• aesthetic outcome

  1 year

• complications (infection, hematoma, capsular contracture)

  1 year

• Patient satisfaction

  1 year

Study Arms (2)

Traditional Method

ACTIVE COMPARATOR

Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander

Procedure: Serratus anterior to cover lateral aspect of tissue expander

Dermamatrix Arm

EXPERIMENTAL

Arm which uses Dermamatrix as the lateral expander coverage

Procedure: Dermamatrix to cover lateral aspect of tissue expander

Interventions

Dermamatrix to cover lateral aspect of tissue expander PROCEDURE

Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy

Also known as: Dermamatrix

Dermamatrix Arm

Serratus anterior to cover lateral aspect of tissue expander PROCEDURE

Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Traditional Method

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2345, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jason J. Wendel, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)