Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap

Study Overview
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Brief Summary
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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.

Official Title
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Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap

Conditions
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Abdominal Donor-site

Intervention / Treatment
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* Device: Biological mesh
* Device: Synthetic mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Immediate or delayed breast reconstruction using the pedicled TRAM-flap Older than 18 years of age Understand enough Danish to comprehend the given information and to complete the study questionnaire Verbal and written informed consent Exclusion Criteria: Current smokers Not eligible patients, assessed by surgeon High level of co-morbidity, assessed by surgeon or anesthesiologist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological mesh (Strattice Firm)<br>Strattice Firm is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. | Device: Biological mesh<br> <br> * Other names: Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.;|
| Experimental: Synthetic mesh (Prolene)<br>Prolene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. | Device: Synthetic mesh<br> <br> * Other names: Prolene mesh, Ethicon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal donor site morbidity | Bulge Definition: visible abdominal contour abnormality, without the presence of a fascial defect, with or without the need for surgical correction. Assessed after 3-4, 12 and 24 months by clinical examination and after 12 and 24 months by CT scanning including the Valsalva maneuver Hernia Definition: abdominal wall bulge with the presence of a palpable fascial defect and/or a fascial defect found during an additional correcting surgical procedure or by CT scanning. Assessed after 3-4, 12 and 24 months by clinical examination and after 12 and 24 months by CT scanning including the Valsalva maneuver Abdominal donor site correction procedure (within 24 months) Pain/ discomfort Assessed after 3-4, 12 and 24 months by DoloTest® Study specific questionnaire regarding postoperative assessment of abdominal pain/ discomfort including effect on daily life activities and ability to perform sport | 24 months | 
| Aesthetics at the abdominal wall | Study specific questionnaire regarding postoperative assessment of the outcome including: Overall satisfaction with the appearance of the abdominal donor site Satisfaction regarding placement and the appearance of the umbilicus Investigators assessment of the abdominal donor site including: Visual bulging of the lower abdomen Placement and appearance of the umbilicus Appearance of the scar | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Synthetic mesh, Abdominal donor-site, Breast reconstruction, Biological mesh