SurgiMend® vs. Strattice™ in Direct to Implant Breast Reconstruction- A Prospective Randomized Trial

NCT02521623 | Completed DMC

• 1 other identifier: 48607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing number of women undergo an immediate breast reconstruction, where the mastectomy and the breast reconstruction are performed in the same surgery. To aid survival of the mastectomy skin flaps, and to provide better aesthetic results acellular dermal matrixes (ADMs) are used to reinforce the breast. There are several different types of ADM available for this purpose. In this randomized clinical trial, the following study will investigate two different types of ADM (Strattice™ and SurgiMend®) in an immediate breast reconstructive setting. Sixty patients will be allocated on a 1:1 ratio to receive either Strattice™ or SurgiMend® ADM. Patients scheduled for immediate breast reconstruction with ADM at pt. of Plastic and Reconstructive Surgery at Aarhus University Hospital, Aarhus, Denmark will be offered participation. In total, 60 patients will be included. Outcome parameters of interest are complication rate, patient satisfaction, aesthetic result and cost of the procedure. Satisfaction and aesthetic result will be measured at 4 and 12 months post surgery.

Conditions

Breast Neoplasms

Keywords

Acelullar Dermal Matrix; Immediate Breast Reconstruction; Breast Implant

Outcome Measures

Primary Outcomes (1)

• Complication Rate

  The prevalence of complications to the BR.

  1 year from surgery

Secondary Outcomes (3)

• Patients reported satisfaction

  1 year

• Aesthetic result

  1 year

• Cost of Care

  1 year

Study Arms (2)

Surgimend

EXPERIMENTAL

Patients randomized to this arm will receive SurgiMend® Acellular Dermal Matrix in their direct to implant primary breast reconstruction.

Device: SurgiMend® Acellular Dermal Matrix

Strattice

ACTIVE COMPARATOR

Patients randomized to this arm will receive Strattice™ Acellular Dermal Matrix in their direct to implant primary breast reconstruction.

Device: Strattice™ Acellular Dermal Matrix

Interventions

SurgiMend® Acellular Dermal Matrix DEVICE

See arm description.

Surgimend

Strattice™ Acellular Dermal Matrix DEVICE

See arm description.

Strattice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has been deemed eligible for an immediate breast reconstruction using implant and ADM by the responsible plastic and breast surgeon
• Patient is older than 18 years of age
• Patient understand enough Danish to comprehend the given information and to complete the study questionnaires

You may not qualify if:

• Current smokers (patients not having paused for a minimum of four weeks prior to surgery)
• Non-eligible patients, as assessed by operating surgeon
• High level of co-morbidity, as assessed by operating surgeon or anesthesiologist

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Dept. of Plastic Surgery, Aarhus University Hospital

Aarhus C, Jutland, 8000, Denmark

Location

Related Publications (20)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tine E Damsgaard, MD, PHD

  Plastic Surgery Research Unit, Dept. of Plastic Surgery, Aarhus University Hospital, Aarhus, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.-student

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)