Immediate Breast Reconstruction With Acellular Dermal Matrix

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Mammaplasty; Breast Carcinoma in Situ; Acellular Dermis
• Intervention / Treatment: Procedure: one-stage technique

• Study Type: Observational
• Enrollment (Actual): 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients were all women admitted for immediate, implant-based breast reconstruction following skin-sparing mastectomy at the Department of Plastic and Breast Surgery, Aarhus University Hospital, Denmark from September 2010 to January 2014.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
One-stage group; Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix.	Procedure: one-stage technique; breast reconstruction in one stage using silicone implant and acellular dermal matrix.
Two-stage group; Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: 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)
• Investigators: Principal Investigator: Mette Eline Brunbjerg, MD, Aarhus University Hospital, Aarhus University, Denmark

Publications and helpful links

General Publications

• Brunbjerg ME, Jensen TB, Overgaard J, Christiansen P, Damsgaard TE. Comparison of one-stage direct-to-implant with acellular dermal matrix and two-stage immediate implant-based breast reconstruction-a cohort study. Gland Surg. 2021 Jan;10(1):207-218. doi: 10.21037/gs-20-581.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): March 17, 2016
• Study Completion (Actual): March 17, 2016

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ
• Other Study ID Numbers: VEK 1-10-72-572-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No