Immediate Breast Reconstruction With Acellular Dermal Matrix

Completed

• Conditions: Acellular Dermis; Mammaplasty; Breast Cancer; Breast Carcinoma in Situ
• Interventions: Procedure: one-stage technique

• Registration Number: NCT04209010
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-01
• Primary Completion: 2016-03-17
• Study Completion: 2016-03-17
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
One-stage group	one-stage technique	Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	3 months	Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.

Secondary Outcome Measures

Name	Time	Method
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.