Clinical trial · Interventional
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study
NCT02061527CI-TRIAL-00032651completedN/AClinicalTrials.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)
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial submuscular coverage | Procedure | — | UNRESOLVED |
| Reconstruction with ADM. | Procedure | — | UNRESOLVED |
| Reconstruction with implant | Procedure | — | UNRESOLVED |
| Skin or nipple sparing mastectomy | Procedure | — | UNRESOLVED |
| Total submuscular coverage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast reconstruction with ADM
- description
- Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.
- interventionNames
- Procedure: Reconstruction with ADM.
- Procedure: Skin or nipple sparing mastectomy
- Procedure: Reconstruction with implant
- Procedure: Partial submuscular coverage
- type
- ACTIVE_COMPARATOR
- label
- Breast reconstruction without ADM
- description
- Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.
- interventionNames
- Procedure: Skin or nipple sparing mastectomy
- Procedure: Reconstruction with implant
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral) * Patient agrees to participate in study and to sign an informed consent form * Able and willing to return for all scheduled and required study visits Exclusion Criteria: * Is a smoker (patient having quit at least 4 weeks prior surgery can be included) * BMI \<18 or \> 30 * Previous radiation therapy to the region at any time * Insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies * Predicted implant size \<200 or \>600 ml per investigator assessment * Allergy to porcine * Pregnancy or lactating * Current enrollment or plans to enroll in another clinical trial unless a retrospective study * Neoadjuvant treatment with chemotherapy
References
Publications (2)
- DERIVEDLohmander F, Lagergren J, Johansson H, Roy PG, Brandberg Y, Frisell J. Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127806. doi: 10.1001/jamanetworkopen.2021.27806. PMID 34596671
- DERIVEDLohmander F, Lagergren J, Johansson H, Roy PG, Frisell J, Brandberg Y. Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial. BJS Open. 2020 Oct;4(5):811-820. doi: 10.1002/bjs5.50324. Epub 2020 Aug 6. PMID 32762012