Acellular Dermis, Breast Cancer, Breast Carcinoma in Situ, Mammaplasty
Conditions
Brief summary
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.
Interventions
PROCEDUREone-stage technique
breast reconstruction in one stage using silicone implant and acellular dermal matrix.
Sponsors
Danish Cancer Society
The Korning foundation
Foundation of the Kjaersgaard Family
King Christian X foundation
Foundation of architect Holger Hjortenberg
LifeCell Corporation (Branchburg, NJ, USA)
Aarhus University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 3 months | Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient assessed satisfaction with aesthetic result | 2 years | 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. |
| Investigator assessed satisfaction with aesthetic result | 2 years | Assessment of result with and without clothes, symmetry (including measurements of sternal notch-papil distance and papilla-inframammary fold distance). Obtained by clinical examination. |
| Patient reported outcome measures | 2 years | 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. |
| Cost | 2 years | cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions. |
Outcome results
None listed