Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction

NCT01310075 | Completed Results DMC

• 2 other identifiers: 2010-0324NCI-2011-01477
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.

Conditions

Breast Cancer

Keywords

Mastectomy; Bioprosthetic Mesh; Breast Reconstruction; Tissue Expander; Alloderm; Surgimend

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complications After Tissue Expander Replacement With Implant

  through study completion, an average of 1 year

Study Arms (3)

Alloderm Mesh

EXPERIMENTAL

Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.

Device: Alloderm

Surgimend Mesh

EXPERIMENTAL

Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.

Device: Surgimend

Control (no mesh)

NO INTERVENTION

Interventions

Alloderm DEVICE

6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.

Alloderm Mesh

Surgimend DEVICE

10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.

Surgimend Mesh

Eligibility Criteria

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

You may qualify if:

• Patients undergoing immediate tissue expander reconstruction following mastectomy by any of the surgeon co-investigators are eligible for the study.
• Patients 18 years of age or older are eligible for the study.
• Patients undergoing skin-sparing mastectomy utilizing bioprosthetic mesh are eligible for the study.
• Patients who have not undergone autologous tissue breast reconstruction and intend to undergo implant only breast reconstruction.
• Patients who intend to remain under the MDACC surgeon's care until completion of the reconstruction.

You may not qualify if:

• Patients with prior radiation to the breast/chest wall of the ipsilateral breast .
• Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh.
• Patients who are current smokers.
• Patients requiring additional intra-operative skin resections of greater than 1cm beyond the skin edge as a result of mastectomy flap devascularization.
• Patients who have a history of breast tissue expander or implant placement.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Mark W Clemens, Associate Professor, Plastic Surgery
• Organization: UT MD Anderson Cancer Center

mwclemens@mdanderson.org

713-794-1247

Study Officials

• Mark W. Clemens, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 7, 2011
• Study Start: February 1, 2011
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Locations

US (1)