Clinical trial · Interventional
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
NCT01781299CI-TRIAL-00027544completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.
Conditions
Conditions (2)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AlloDerm RTU | Device | — | UNRESOLVED |
| SurgiMend PRS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AlloDerm RTU
- description
- Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
- interventionNames
- Device: AlloDerm RTU
- type
- ACTIVE_COMPARATOR
- label
- SurgiMend PRS
- description
- Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
- interventionNames
- Device: SurgiMend PRS
Primary outcomes (1)
- measure
- Complication Rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject's with ability to provide informed consent. 2. Subjects greater than 18 years old 3. Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and 4. Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits. Exclusion Criteria: 1. Subjects less than 18 years of age 2. Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product 3. Pregnancy 4. Bovine allergy
References
Publications (14)
- BACKGROUNDBreuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg. 2005 Sep;55(3):232-9. doi: 10.1097/01.sap.0000168527.52472.3c. PMID 16106158
- BACKGROUNDGamboa-Bobadilla GM. Implant breast reconstruction using acellular dermal matrix. Ann Plast Surg. 2006 Jan;56(1):22-5. doi: 10.1097/01.sap.0000185460.31188.c1. PMID 16374090
- BACKGROUNDTopol BM, Dalton EF, Ponn T, Campbell CJ. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of the lower pole of the breast to reduce unwanted lift. Ann Plast Surg. 2008 Nov;61(5):494-9. doi: 10.1097/SAP.0b013e31816d82d9. PMID 18948774
- BACKGROUNDMaxwell GP, Gabriel A. Possible future development of implants and breast augmentation. Clin Plast Surg. 2009 Jan;36(1):167-72, viii. doi: 10.1016/j.cps.2008.08.005. PMID 19055971
- BACKGROUNDStump A, Holton LH 3rd, Connor J, Harper JR, Slezak S, Silverman RP. The use of acellular dermal matrix to prevent capsule formation around implants in a primate model. Plast Reconstr Surg. 2009 Jul;124(1):82-91. doi: 10.1097/PRS.0b013e3181ab112d. PMID 19568048
- BACKGROUNDNamnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009 Aug;124(2):387-394. doi: 10.1097/PRS.0b013e3181aee95b. PMID 19644253
- BACKGROUNDGrabov-Nardini G, Haik J, Regev E, Winkler E. AlloDerm Sling for Correction of Synmastia After Immediate, Tissue Expander, Breast Reconstruction in Thin Women. Eplasty. 2009 Nov 12;9:e54. PMID 20011582
- BACKGROUNDSbitany H, Sandeen SN, Amalfi AN, Davenport MS, Langstein HN. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009 Dec;124(6):1735-1740. doi: 10.1097/PRS.0b013e3181bf803d.