Clinical trial · Observational
Evaluation of ADM Soft Tissue Reinforcement
Post-operative Outcomes as Clinical Evidence for Soft Tissue Reinforcement: a Prospective Cohort Study.
- 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 use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Despite such widespread acceptance among both patients and plastic surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug Administration (FDA) for use of their product as a medical device in breast reconstructions. ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit "soft tissue reinforcement of integument" to be considered a medical device, a criterion that has yet to be physiologically or clinically defined. This distinction precludes the development and manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks after surgery. The investigators propose a prospective cohort study to determine whether post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement within the ADM group.
Conditions
Conditions (3)
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 |
| Surgery | — | UNRESOLVED | — |
| Surgical Item, Retained | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acellular dermal matrix | Device | — | UNRESOLVED |
| Direct-to-implant breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ADM
- description
- Patients having undergone direct-to-implant breast reconstruction using acellular dermal matrix.
- interventionNames
- Procedure: Direct-to-implant breast reconstruction
- Device: Acellular dermal matrix
- label
- Non-ADM (Vicryl)
- description
- Patients having undergone direct-to-implant breast reconstruction using non-acellular dermal matrix mesh (Vicryl mesh).
- interventionNames
- Procedure: Direct-to-implant breast reconstruction
Primary outcomes (2)
- measure
- Change in Tissue thickness (measured in millimeters).
- timeFrame
- Post-surgical, follow-up intervals extending to one year following reconstruction. Measurements will be performed at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * direct to implant breast reconstruction Exclusion Criteria: * BMI \> 30 * history of smoking within 1 year of enrollment * previous breast surgery * malnutrition or cachexia * breast implant volume ≤ 125 mL or ≥ 700 mL
References
Publications (0)
Data not yet available