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NCT00872859 · ClinicalTrials.gov registry record · Phase 4

The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

A Phase 4 study, sponsored by University of Utah.

Completed
Registry status
Phase 4
Development phase
128
Enrollment target

NCT00872859 is a Phase 4 study that has completed, run by University of Utah. The registered enrollment target is 128 participants.

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The verdict

NCT00872859, a Phase 4 study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 4
Development phase
128 participants
Enrollment target

Study Summary

Primary Hypothesis: 1\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation. 2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation. 3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix Specific aims: 1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation 2. Compare the complication rates between the two types of acellular dermal matrix 3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation. 4. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation

Interventions

  • PROCEDURE Implantation of Dermal Matrix substitute

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2008-10
Est. Completion 2015-02
Phase Phase 4

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT00872859

The ClinicalTrials.gov registry entry for NCT00872859 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Implantation of Dermal Matrix substitute is the first listed.

NCT00872859 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00872859 about?

NCT00872859 is a clinical study titled "The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial". Primary Hypothesis: 1\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared...

What is the current status of trial NCT00872859?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2008-10. Estimated completion is 2015-02.

What interventions are being tested in trial NCT00872859?

The interventions under investigation include: Implantation of Dermal Matrix substitute (PROCEDURE).

Who is sponsoring clinical trial NCT00872859?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.