Completed

Evaluation of SurgiMend® vs. Strattice™ in Direct-to-Implant Breast Reconstruction

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What is being tested

SurgiMend® Acellular Dermal Matrix

+ Strattice™ Acellular Dermal Matrix

Device
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

From 18 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2015
See protocol details

Summary

Principal SponsorAarhus University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2015

Actual date on which the first participant was enrolled.

This study focuses on women who choose to undergo a risk-reducing mastectomy, a procedure to remove breast tissue to lower the risk of breast cancer. This is often chosen by women with a high genetic risk or those diagnosed with multifocal DCIS. The study aims to improve the immediate breast reconstruction process that follows the mastectomy. Currently, acellular dermal matrixes (ADMs) are used to support the skin and implant during reconstruction. The study aims to find the best ADM for this purpose, to minimize complications and improve patient satisfaction. Two types of ADMs, SurgiMend® and Strattice™, will be evaluated. The study's hypothesis is that both provide equal results in terms of complication rates, patient feedback, and aesthetic appearance. Patients participating in the study will be randomly assigned to receive either SurgiMend® or Strattice™ ADM. The surgical procedure remains the same regardless of the ADM used. Patients will be asked to complete a questionnaire before and 4 and 12 months after their breast reconstruction. This questionnaire, known as BREAST-Q, assesses body image, satisfaction with breasts, and satisfaction with care. Additionally, the aesthetic result of the reconstruction will be evaluated by an investigator at 4 and 12 months. Participants may experience risks associated with the mastectomy and reconstruction, such as wound infection, blood clots, and altered sensation. However, these risks are not related to participation in the study. Participants will need to spend extra time completing questionnaires and attending additional clinical examinations.

Official TitleSurgiMend® vs. Strattice™ in Direct to Implant Breast Reconstruction- A Prospective Randomized Trial
NCT02521623
Principal SponsorAarhus University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

3 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Dept. of Plastic Surgery, Aarhus University Hospital

Aarhus C, DenmarkOpen Dept. of Plastic Surgery, Aarhus University Hospital in Google Maps
CompletedOne Study Center