Clinical trial · Interventional
Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
A Randomized Controlled Trial Comparing the Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
- 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)
Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. There is a lack of studies documenting outcomes following ADM-assisted prepectoral breast reconstruction, and there are no randomised controlled trial studies that drawing a direct comparison of clinical or patient-reported outcomes between subpectoral and prepectoral groups. The investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in less early postoperative pain but more reported implant rippling, requirement of more fat grafting and an equitable safety profile compared with ADM-assisted implant-based breast reconstruction with subpectoral implant placement. The aim of this study is to evaluate the postsurgical pain, complications and patient-reported outcomes of prepectoral breast reconstruction versus subpectoral implant placement in immediate breast reconstruction.
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 |
|---|---|---|---|
| immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. | Procedure | — | UNRESOLVED |
| Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prepectoral implant placement
- description
- Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
- interventionNames
- Procedure: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
- type
- ACTIVE_COMPARATOR
- label
- Subpectoral implant placement
- description
- Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.
- interventionNames
- Procedure: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Female patient * Ages 20-80 * All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction * Able to provide informed consent Exclusion Criteria: * Patients who have had prior chest wall or irradiation on the reconstructed side * Patients not undergoing immediate breast reconstruction at the time of mastectomy * Any patient with a contraindication to immediate breast reconstruction. * Patients with history of smoking, BMI\> 40, and D cup breast size or grade III ptosis are all contraindications to immediate breast reconstruction as the risk of postoperative complications are significantly higher (wound infection, dehiscence, implant loss, seroma) than the average patient and thus these patients would be excluded from the study.
References
Publications (0)
Data not yet available