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Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction

NCT01310075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-04-30

Study results available
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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

Interventions

DEVICE

Alloderm

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

Surgimend

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Mark W. Clemens, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2017-11-08
Completion
2017-11-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01310075 on ClinicalTrials.gov