Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
Study NCT ID:
NCT00872859
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2009-03-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: