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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: Completed Phase 4 study, sponsored by University of Utah.

NCT00872859 is a Phase 4 study that has completed, run by University of Utah. The registered enrollment target is 128 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
University of Utah

818 total trials

What the finished NCT00872859 record still lists

NCT00872859 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

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

NCT00872859 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00872859's enrollment target sits among peer trials

128 634th of 2000 higher than 1,362 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00872859, the US trial registry maintained by the National Library of Medicine. NCT00872859 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.