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Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Sponsor
University of California, Los Angeles (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05190978
Collaborator
University of Michigan (Other), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Other), Weill Medical College of Cornell University (Other)
120
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

Condition or Disease Intervention/Treatment Phase
  • Device: Acellular Dermal Matrix
  • Procedure: Reconstruction without ADM
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Patients will blinded to whether they receive ADM products during their reconstruction.
Primary Purpose:
Treatment
Official Title:
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acellular Dermal Matrix

Patients will receive ADM during their initial tissue expander placement.

Device: Acellular Dermal Matrix
Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
Active Comparator: Control

Patients will not receive ADM during their initial tissue expander placement.

Procedure: Reconstruction without ADM
Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.

Outcome Measures

Primary Outcome Measures

  1. Safety - Major Complications [2 years]

    Relative rate of major complications (requiring unplanned re-admission or re-operation)

  2. Effectiveness - BREASTQ [2 years]

    BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.

Secondary Outcome Measures

  1. Secondary Effectiveness [2 years]

    Time from expander placement to implant exchange

  2. Secondary Safety [2 years]

    Individual complication rates

  3. Capsular Contracture [2 years]

    Rate of capsular contracture

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders

  • Prophylactic and oncologic mastectomies are both acceptable

  • Nipple sparing and skin sparing mastectomy techniques are both acceptable

Exclusion Criteria:

  • Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast

  • Bilateral reconstruction patients undergoing contralateral submuscular reconstruction

  • Direct-to-implant reconstruction

  • Pregnancy

  • Delayed reconstruction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, Los Angeles
  • University of Michigan
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Michael Delong, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael R. Delong, Fellow, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT05190978
Other Study ID Numbers:
  • 190311
First Posted:
Jan 13, 2022
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Michael R. Delong, Fellow, University of California, Los Angeles
breast cancer
breast reconstruction
breast implant
Additional relevant MeSH terms:
Inflammation

Study Results

No Results Posted as of Jan 13, 2022