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| Name | Class |
|---|---|
| LifeCell | INDUSTRY |
| Novo Nordisk A/S | INDUSTRY |
| University of Aarhus | OTHER |
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The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.
The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.
The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological mesh (Strattice Firm) | Experimental | Strattice Firm is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. |
|
| Synthetic mesh (Prolene) | Experimental | Prolene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological mesh | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal wall function change | Strength of abdominal wall is assessed by a standardized physical examination developed in collaboration with physiotherapists. A dynamometer is used to get an exact value of muscle strength. | Change from before surgery to 12 and 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal donor site morbidity | Bulge
Hernia
Abdominal donor site correction procedure (within 24 months) Pain/ discomfort
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette Eline Brunbjerg, MD | Aarhus University Hospital and Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Plastic and Reconstructive Surgery, Aarhus University Hospital | Aarhus C | Aarhus | 8000 | Denmark |
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| Synthetic mesh | Device |
|
|
| 24 months |
| Aesthetics at the abdominal wall | Study specific questionnaire regarding postoperative assessment of the outcome including:
Investigators assessment of the abdominal donor site including:
| 24 months |
| Costs | National health insurance rate Cost of Strattice (LifeCell), Prolene mesh (Ethicon) Operation time Hospitalization Time to return to work / Duration of sick leave Post-reconstruction procedures to address complications at the abdominal donor site. | 24 months |
| Postoperative complications | Hematoma requiring surgical intervention. Cellulitis/ wound infection not requiring surgical intervention but treatment with antibiotics. Infection requiring surgical intervention. Seroma requiring intervention Donor site necrosis (present necrosis - excluding epidermolysis, in the umbilical area or in the remaining abdominal skin and subcutaneous tissue requiring surgical intervention) | Acute <1 month, ≥ 1 month-24 months |