Clinical trial · Interventional
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI is no longer at institution. IRB closed study due to lack of response from PI
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alloderm | Biological | — | UNRESOLVED |
| FlexHD | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FlexHD
- description
- Patients randomly assigned to receive FlexHD for breast reconstruction.
- interventionNames
- Biological: FlexHD
- type
- ACTIVE_COMPARATOR
- label
- Alloderm
- description
- Patients randomly assigned to receive Alloderm for breast reconstruction.
- interventionNames
- Biological: Alloderm
Primary outcomes (1)
- measure
- Wound Dehiscence
- timeFrame
- One Year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDYuen 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. PMID 25289313
- BACKGROUNDLiu 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. PMID 23636114
- BACKGROUNDBrooke 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. PMID 22868313