Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

Breast Neoplasm Clinical Trial

Official title:

Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02372305
• Other study ID #: 203456
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: July 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Biological:
• FlexHD
Patients will be randomized to receive FlexHD.
• Alloderm
Patient will be randomized to receive Alloderm.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brooke S, Mesa J, Uluer M, Michelotti B, Moyer K, Neves RI, Mackay D, Potochny J. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012 Oct;69(4):347-9. doi: 10.1097/SAP.0b013e31824b3d97. — View Citation

Liu DZ, Mathes DW, Neligan PC, Said HK, Louie O. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014 May;72(5):503-7. doi: 10.1097/SAP.0b013e318268a87c. — View Citation

Yuen JC, Yue CJ, Erickson SW, Cooper S, Boneti C, Henry-Tillman R, Klimberg S. Comparison between Freeze-dried and Ready-to-use AlloDerm in Alloplastic Breast Reconstruction. Plast Reconstr Surg Glob Open. 2014 Apr 7;2(3):e119. doi: 10.1097/GOX.0000000000000061. eCollection 2014 Mar. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Dehiscence	time frame.	One Year