Clinical trial · Interventional
Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M)
Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue
- 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)
Some women with breast cancer have their whole breast removed as part of their treatment (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are two main ways to create a new breast(i)using tissue from elsewhere on the body ("autologous" reconstruction )or (ii)using a silicone implant. In recent years, it has been reported that by using a material called an "acellular dermal matrix" (ADM) the results of breast reconstruction surgery using an implant can be improved. ADMs are materials which originally come from animal or human skin. They act like a sling, supporting the lower part of an implant beneath the skin. Although ADMs have been approved for used in breast reconstruction and are safe, there is very little high quality evidence to back up their reported benefits, and some studies have suggested their use may in fact increase complications. The main purpose of this study is to find out what the actual risks and benefits of using an ADM in breast reconstruction surgery are. The investigators will follow the progress of women who have an implant based reconstruction to observe if participants develop problems; what those problems are and how participants feel about the results of their surgery. The investigators also follow the progress of women who undergo autologous reconstruction or alternative reconstructive techniques using an implant for the same reasons.
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 Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstruction- autologous tissue | Procedure | — | UNRESOLVED |
| Breast reconstruction - implant and an ADM (SurgiMend) | Procedure | — | UNRESOLVED |
| Breast reconstruction- implant + dermal sling/LD flap | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Implant and Surgimend
- description
- Breast reconstruction surgery with an implant and an ADM (Surgimend)
- interventionNames
- Procedure: Breast reconstruction - implant and an ADM (SurgiMend)
- type
- ACTIVE_COMPARATOR
- label
- Autologous tissue
- description
- Breast reconstruction surgery with autologous tissue
- interventionNames
- Procedure: Breast reconstruction- autologous tissue
- type
- ACTIVE_COMPARATOR
- label
- Implant + dermal sling/LD flap
- description
- Breast reconstruction surgery using a dermal sling or a latissimus dorsi (LD)flap
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent given * Unilateral or bilateral mastectomy (therapeutic, contra lateral or prophylactic) * Immediate reconstruction; * Suitable for immediate implant reconstruction with ADM Exclusion Criteria: * Patients unable to provide informed consent to participate in trial * Patients unavailable for follow-up * Not eligible for immediate breast reconstruction using an ADM
References
Publications (0)
Data not yet available