Immediate Breast Reconstruction With Acellular Dermal Matrix

Study Overview
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Brief Summary
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The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.

Official Title
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Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study

Conditions
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Breast Cancer, Breast Carcinoma in Situ, Mammaplasty, Acellular Dermis

Intervention / Treatment
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* Procedure: one-stage technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer Mastectomy weight ≤ 600 g Patient older than 18 years Ability to complete the study questionnaire Only for the two-stage group no later than 2 years and 4 months from breast reconstruction Exclusion Criteria: - smokers

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One-stage group<br>Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix. | Procedure: one-stage technique<br>* breast reconstruction in one stage using silicone implant and acellular dermal matrix.<br>|
| Two-stage group<br>Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart. | 3 months | 
| Postoperative complications | Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient assessed satisfaction with aesthetic result | Assessment of result with and without clothes, symmetry and all-in-all satisfaction with result. Obtained by questionnaire on a 7 point Likert scale. Higher score equals higher satisfaction. | 2 years | 
| Investigator assessed satisfaction with aesthetic result | Assessment of result with and without clothes, symmetry (including measurements of sternal notch-papil distance and papilla-inframammary fold distance). Obtained by clinical examination. | 2 years | 
| Patient reported outcome measures | Patient reported assessment of pain and dysaesthesia in reconstructed breast, arm/shoulder function on reconstructed side. Described on a 6 point scale where lower score equals more pain/dysaesthesia/troubles with arm/shoulder function. Body image (Hopwoods Body Image Scale) assessed in a 10-items each on 4 point Likert scale from 0 to 3. Sum provides a total score (range 0-30) and lower scores equals less body image troubles. Furthermore, study specific questions as use of pain killers the last week (yes / no) and all in all assessment of health owning to the breast reconstruction (improved / diminished or unchanged). All obtained by questionnaire. | 2 years | 
| Cost | cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions. | 2 years |