Clinical trial · Interventional
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
NCT05316324CI-TRIAL-00103419active not recruitingPhase 3ClinicalTrials.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 researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) | Procedure | — | UNRESOLVED |
| Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prepectoral Breast Reconstruction with ADM
- interventionNames
- Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)
- type
- EXPERIMENTAL
- label
- Prepectoral Breast Reconstruction without ADM
- interventionNames
- Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
Primary outcomes (1)
- measure
- Percentage of patients who experience major complications
- timeFrame
- 90 days
- description
- Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): * Infection defined as: * Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics * Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics * Purulent drainage from the surgical site or incision * Explantation defined as the need for removal of a TE for any cause * Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged 21-60 years * Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer * Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage * Planning to undergo nipple-sparing or skin-sparing mastectomy * Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion * Intraoperative confirmation of prepectoral plane viability by operating physician Exclusion Criteria: * History of radiotherapy to the operative breast * Current smoker * Non-English speaking patients * Planning to undergo direct-to-implant reconstruction * Prior sternotomy
References
Publications (1)
- DERIVEDNelson JA, Shammas RL, Boe LA, Gonen M, Poulton RT, Stern CS, Rochlin DH, McCarthy CM, Allen RJ Jr, Coriddi M, Disa JJ, Mehrara BJ, Matros E. Two-Stage Prepectoral Breast Reconstruction with and without Acellular Dermal Matrix: A Cluster-Randomized Noninferiority Trial. Plast Reconstr Surg. 2026 Mar 11. doi: 10.1097/PRS.0000000000013019. Online ahead of print. PMID 41811168