Clinical trial · Interventional
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
Prospective Randomized Control Study About the Effect of Postmastectomy Radiation Therapy on Capsular Contracture in Patients With Prepectoral or Subpectoral Implant-based Breast Reconstruction: PREPER Trial
- 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 prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in lower risk of capsular contracture after postmastectomy radiation therapy(PMRT) compared with acellular dermal matrix(ADM)-assisted implant-based breast reconstruction with subpectoral implant placement.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm I (Prepectoral), Arm II (Subpectoral) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- I (Prepectoral)
- description
- Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
- interventionNames
- Procedure: Arm I (Prepectoral), Arm II (Subpectoral)
- type
- ACTIVE_COMPARATOR
- label
- II (Subpectoral)
- description
- Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.
- interventionNames
- Procedure: Arm I (Prepectoral), Arm II (Subpectoral)
Primary outcomes (2)
- measure
- Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 19 years old 2. Histologically confirmed diagnosis of unilateral breast cancer 3. Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication 4. Patient undergoing immediate implant based breast reconstruction Exclusion Criteria: 1. Underlying medical condition: for example, (AST or ALT \>100U/L, inadequate renal function; eGFR \< 30ml/min, congestive heart failure; New York Heart Association III-IV) 2. Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy 3. History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded. 4. Not able to provide informed consent (Illiterate, foreigners, etc.)
References
Publications (0)
Data not yet available