Expired Study
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McLean, Virginia 22102


Purpose:

The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.


Criteria:

Inclusion Criteria: - Patients having immediate breast reconstruction with tissue expanders - Unilateral or bilateral reconstructions - Ages 25 - 65 - All breast cancer stages and types Exclusion Criteria: - BMI > 35 - Active smokers - Diabetics - History of radiation or planned radiation - Immunocompromised patients


Study is Available At:


Original ID:

11.064


NCT ID:

NCT01372917


Secondary ID:


Study Acronym:


Brief Title:

Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study


Official Title:

Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

25 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Plastic Surgery, Virginia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: C


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

39


Enrollment Type:

Actual


Study Dates

Start Date:January 2010
Completion Date:August 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 11, 2012
First Received Date:June 13, 2011

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Allomax
Description:The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:National Center for Plastic Surgery, Virginia
Agency Class:Other
Agency Type:Collaborator
Agency Name:Inova Health Care Services

Samples and Retentions

Sample Retention:Samples Without DNA
Description: A 1 cm square of AlloMax will be harvested from the first 20 patients for histologic examination to determine wether or not there is neovascularization and collagen deposition.
Study Population: Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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