Immediate Breast Reconstruction With Acellular Dermal Matrix

NCT04209010 | Completed

• 1 other identifier: VEK 1-10-72-572-12
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Breast Carcinoma in Situ; Mammaplasty; Acellular Dermis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Patient assessed satisfaction with aesthetic result

  2 years

• Investigator assessed satisfaction with aesthetic result

  2 years

• Patient reported outcome measures

  2 years

• Cost

  2 years

Study Arms (2)

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

Two-stage group

Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique.

Interventions

one-stage technique PROCEDURE

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

One-stage group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- smokers

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Danish Cancer Society: collaborator
• The Korning foundation: collaborator
• Foundation of the Kjaersgaard Family: collaborator
• King Christian X foundation: collaborator
• Foundation of architect Holger Hjortenberg: collaborator
• LifeCell Corporation (Branchburg, NJ, USA): collaborator

Related Publications (1)

• 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.

  PMID: 33633977 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mette Eline Brunbjerg, MD

  Aarhus University Hospital, Aarhus University, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, Principal Investigator

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 23, 2019
• Study Start: December 1, 2012
• Primary Completion: March 17, 2016
• Study Completion: March 17, 2016
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share