Clinical trial NCT02372305: Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
Official title: Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Breast Neoplasm
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Wound Dehiscence
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: Pallavi A Kumbla, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.