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Evaluation of ADM Soft Tissue Reinforcement

NCT03494244 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2019-03-12

No results posted yet for this study

Summary

The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Despite such widespread acceptance among both patients and plastic surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug Administration (FDA) for use of their product as a medical device in breast reconstructions. ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit "soft tissue reinforcement of integument" to be considered a medical device, a criterion that has yet to be physiologically or clinically defined. This distinction precludes the development and manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks after surgery. The investigators propose a prospective cohort study to determine whether post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement within the ADM group.

Conditions

Interventions

PROCEDURE

Direct-to-implant breast reconstruction

Terminal prosthetic implanted at the time of mastectomy.

DEVICE

Acellular dermal matrix

Banked tissue used to support the directly implanted breast prosthesis.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2022-04-01
Completion
2022-04-01
FDA Device
Yes

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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 NCT03494244 on ClinicalTrials.gov