Immediate Breast Reconstruction With Acellular Dermal Matrix

N/ACompletedNCT04209010

Aarhus University Hospital44 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Breast Carcinoma in Situ Mammaplasty Acellular Dermis

Interventions

one-stage techniquePROCEDURE

breast reconstruction in one stage using silicone implant and acellular dermal matrix.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative complications

Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.

Time frame: 3 months

Postoperative complications

Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 years

Cost

cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions.

Data from ClinicalTrials.gov

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