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NCT01561287 · ClinicalTrials.gov registry record · Phase 4

A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction

A Phase 4 study of Breast Cancer and Breast Reconstruction, sponsored by University of Kentucky.

Completed
Registry status
Phase 4
Development phase
48
Enrollment target
1
Study location

NCT01561287 is a Phase 4 study of Breast Cancer and Breast Reconstruction that has completed, run by University of Kentucky. The registered enrollment target is 48 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01561287, a Phase 4 study of Breast Cancer and Breast Reconstruction, has completed, sponsored by University of Kentucky.

COMPLETED
Registry status
Phase 4
Development phase
48 participants
Enrollment target
1
Study location

Study Summary

Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients. A reconstructive sequence consisting of a tissue expander followed by permanent implant placement is a popular choice for many women. In the past several years, acellular dermal matrices (allografts) have been used at the time of tissue expander placement to extend submuscular coverage. Reported benefits include the ability to initially fill the expander to a greater extent, improved control of the inframammary crease, and possible decrease in capsular contracture rate. Potential disadvantages of dermal allografts include foreign body reaction, incomplete tissue integration, or increased infection rates. The latter is especially worrisome, as infection in the setting of a tissue expander often necessitates the removal of the implant and interruption of the reconstructive sequence. There have been a few scattered reports of the use of dermal autografts in implant-based breast reconstruction, but they have not been widely used. Dermal autografts carry the potential benefit of improved tissue integration and lowered complication rates. However, to date there have been no studies which compare acellular dermal allograft matrices to dermal autograft for use in breast reconstruction. The objectives of this study are to compare dermal allograft to dermal autograft with respect to cost, tissue integration, patient satisfaction with scar, and complication profile in patients undergoing mastectomy followed by tissue expander/implant reconstruction.

Interventions

  • PROCEDURE Dermal Autograft
  • PROCEDURE AlloDerm

Study Locations (1)

Kentucky

  • University of Kentucky Chandler Medical Center - Lexington

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2011-07
Est. Completion 2016-05
Phase Phase 4

Sponsor

University of Kentucky

54 total trials

What the Registry Record Tells You About NCT01561287

The ClinicalTrials.gov registry entry for NCT01561287 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is University of Kentucky, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Dermal Autograft is the first listed.

NCT01561287 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT01561287 about?

NCT01561287 is a clinical study titled "A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction". Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients. A reconstructive sequence consisting of a tissue expander followed by permane...

What is the current status of trial NCT01561287?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2011-07. Estimated completion is 2016-05.

What conditions does trial NCT01561287 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Reconstruction, Mastectomy Related Lymphedema.

What interventions are being tested in trial NCT01561287?

The interventions under investigation include: Dermal Autograft (PROCEDURE), AlloDerm (PROCEDURE).

Who is sponsoring clinical trial NCT01561287?

This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01561287 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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