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

NCT02521623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-06-25

No results posted yet for this study

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

Interventions

DEVICE

SurgiMend® Acellular Dermal Matrix

See arm description.

DEVICE

Strattice™ Acellular Dermal Matrix

See arm description.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Tine E Damsgaard, MD, PHD · Plastic Surgery Research Unit, Dept. of Plastic Surgery, Aarhus University Hospital, Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521623 on ClinicalTrials.gov