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Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372305
Recruitment Status : Withdrawn (PI is no longer at institution. IRB closed study due to lack of response from PI)
First Posted : February 26, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Biological: FlexHD Biological: Alloderm Phase 4

Detailed Description:
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
Study Start Date : March 2016
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FlexHD
Patients randomly assigned to receive FlexHD for breast reconstruction.
Biological: FlexHD
Patients will be randomized to receive FlexHD.

Active Comparator: Alloderm
Patients randomly assigned to receive Alloderm for breast reconstruction.
Biological: Alloderm
Patient will be randomized to receive Alloderm.




Primary Outcome Measures :
  1. Wound Dehiscence [ Time Frame: One Year ]
    time frame.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI<30
  • No Prior Breast Radiation
  • No Prior Breast Reduction
  • No Diabetes Mellitus (IDDM and non-IDDM)
  • Non-smoker or quit >6 weeks prior
  • No breast implants or prior breast implants
  • No inflammatory or autoimmune disorders
  • No current anticoagulation therapy
  • No current pregnant

Exclusion Criteria:

  • BMI > 30
  • Prior Breast Radiation
  • Diabetes Mellitus - IDDM and non IDDM
  • Prior Breast Reduction
  • Active Smoker or Recently Quit <6 weeks
  • Prior Breast Implants
  • Inflammatory/Autoimmune Condition (ex. Lupus)
  • Current Anticoagulation Therapy
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372305


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Pallavi A Kumbla, MD UAMS
Publications:
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02372305    
Other Study ID Numbers: 203456
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases