SurgiMend® vs. Strattice™ in Direct to Implant Breast Reconstruction- A Prospective Randomized Trial
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      Introduction

      An increasing number of Danish women undergo genetic counseling for hereditary breast cancer.
      If the patient´s lifetime risk is evaluated to be more than 30%, the patient may choose to
      undergo a risk-reducing mastectomy (prophylactic mastectomy) to reduce the risk of developing
      breast cancer. The mastectomy is mostly performed as a skin-sparing procedure, where only the
      nipple area and the breast tissue is removed leaving the skin envelope intact, in order to
      preserve the breast skin for an immediate breast reconstruction. In select cases the surgery
      may be performed as a nipple-sparing procedure. Additionally, there is an increasing group of
      women diagnosed with multifocal DCIS who choose risk-reducing mastectomy with an immediate
      reconstruction.

      In order for the risk-reducing mastectomy to be effective, it is of utmost importance that
      all the breast tissue is removed. This leaves the skin flaps covering the breast thin and
      vulnerable to necrosis, if not handled with utmost care. In order to spare the mastectomy
      skin flaps of some of the strain and pressure caused by the breast implants, acellular dermal
      matrixes (ADM) are increasingly used in this type of procedures. ADMs are derived from the
      skin of humans or animals, processed to an extent where their cellular components are
      completely removed, leaving only the extracellular scaffold, thus not inciting an immune
      response from the host. The ADM thus provides a scaffold, promoting integration of the
      patient's own connective tissue. In time the ADM will be repopulated and revascularized by
      the patient's own cells, essentially becoming an integrated part of the patients body. The
      ADM provides optimal definition of the breast borders, essentially allowing improved implant
      positioning as compared with a sub muscular coverage technique. If the circumstance of the
      breast reconstructions necessitates the placement of an expander implant, use of ADMs allows
      for a greater intraoperative expansion, and thus subsequently reduces the number of times the
      patients must attend the outpatient's clinic for expansion of the implant. Thus leading to a
      shorter time before the expander implant may be exchanged for a permanent implant.
      Furthermore, several studies have shown that use of ADM lowers the overall complication rate.

      Several types of ADM are used in a breast reconstructive setting around the world. Strattice™
      is a porcine derived ADM, and has been available in Europe and Denmark since late 2008. In
      order to find the best available ADM for use in a immediate breast reconstructive setting,
      both in terms of complication rates and patient satisfaction, it is crucial that new products
      are continuously evaluated. SurgiMend®, another type of ADM, was recently introduced on the
      Danish market. SurgiMend® ADM is derived from fetal bovine dermis, and recent studies show
      that the use of SurgiMend® ADM is associated with a low early complication rate. Furthermore,
      a recent study provided evidence that ADM derived from bovine have a higher mechanical stress
      tolerance when compared to porcine derived ADM at equivalent thickness.

      Aim

      The aim of the present study is to evaluate two types of ADM´s in an immediate breast
      reconstructive setting. The data from this study will possibly help to minimize complications
      and increase patient satisfaction by finding the optimal ADM for immediate breast
      reconstructions, thereby contributing to a faster recovery for women who undergo mastectomy
      and immediate breast reconstruction with implant and ADM.

      Hypothesis

      SurgiMend and Strattice™ provide equal results in regards to complication rates, patient
      reported outcome measures and aesthetic appearance in patients undergoing immediate breast
      reconstruction.

      Methods

      The project is conducted as a prospective randomized trial. Patients included in the study
      will be randomized to receive either Strattice™ or SurgiMend® ADM. Patients are allocated in
      a 1:1 ratio, with 30 patients receiving Strattice™ ADM and 30 patients receiving SurgiMend®
      ADM. The randomization is performed using a permuted block randomization. Randomization is
      blinded for the patients and the outcome assessor. Regardless of which type of ADM the
      patient is randomized to receive, the surgical procedure will be performed in the same way.

      Patients included in the study will be asked to complete the BREAST-Q pre-reconstruction
      module before their breast reconstruction, and the BREAST-Q post-reconstruction module at 4
      and 12 months after their breast reconstruction. The BREAST-Q is a patient reported outcome
      measure tool specifically designed and validated for use in breast reconstruction patients.
      The BREAST-Q modules consists of several scales, investigating the patients body image,
      satisfaction with breasts and satisfaction with care. The BREAST-Q modules are widely used
      and have been officially translated into the Danish language.

      Participating patients will attend the same standard post-operative controls at 4 and 12
      months after their breast reconstruction as non-participating patients undergoing immediate
      breast reconstruction. In addition to being examined by their operating surgeon at these
      controls, the patients' aesthetic result will be evaluated by one of the investigators using
      a breast reconstruction outcome scale, previously developed at Dept. of Plastic and
      Reconstructive Surgery, Aarhus University Hospital, Aarhus, Denmark. The scale consists of
      six questions evaluating the symmetry, feel, and aesthetic appearance of the reconstructed
      breasts.

      Recruitment of participants

      Patients seeking an immediate breast reconstruction are routinely seen in the Dept. of
      Plastic and Reconstructive Surgery patient clinic by both a consultant breast surgeon and a
      consultant plastic surgeon at the same time. If the breast and plastic surgeon deems the
      patient eligible for a primary breast reconstruction and the plastic surgeon evaluates the
      patient to be best suited with a breast reconstruction based on an implant and ADM, the
      patient will be offered a consultation with the clinical investigator for the project. If the
      plastic surgeon believes that a patient is a better candidate for another type of breast
      reconstructive procedure than implant and ADM, the patient will not be offered participation.

      At the consultation with the investigator, or a well-instructed colleague, the patient will
      be given oral and written information about the research project. The patient will always be
      offered a period of at least 24 hours before deciding to give consent, but may also give her
      informed consent on site. Furthermore, the patient will be offered a second consultation,
      where the information about the project will be repeated and any questions regarding the
      research project she may have will be answered. The patient will also be encouraged to bring
      a family member or friend to the second meeting. The patient may at any time and without need
      of justification withdraw consent to participate, without affecting the present and/or future
      treatment of the patient.

      Risks, side effects and disadvantages

      As with all surgery, there is a risk of wound infection, blood clots and altered sensation in
      the operated area. This can lead to antibiotic treatment, or where appropriate, a second
      operation to stop bleeding or remove damaged tissue. These risks are, however, associated
      with the breast reconstruction itself, and not associated with participating in the current
      study.

      Both types of ADM are well described in the medical literature, and both types of ADM have
      achieved good results compared to not using ADM in immediate breast reconstructions. The
      risks for the patients choosing to participate in the project are thus solely related to the
      breast reconstruction itself, and not to the participation in the current study.

      Participating patients will have to spend approximately 10 minutes completing a questionnaire
      before the breast reconstruction. Additionally, the participating patients will be asked to
      complete another questionnaire (approximately 10 min) at 4 and 12 months after their breast
      reconstruction, as well as participate in an extra clinical examination at their routine
      follow-up examinations after 4 and 12 months. The extra examinations at the routine follow-up
      visits are expected to take approximately 15 min. per visit. While the questionnaire and the
      clinical follow-up may consume some of the patient's time, there are no risks associated with
      them.

      Ethical considerations

      It is expected that the number of women who choose an immediate breast reconstruction
      procedure will increase. Conducting studies that help bring down the complication rates for
      these types of surgery is of utmost importance, both for the individual patient undergoing
      the surgery and in a socio-economic setting.The proposed study will aid in finding the
      optimal method, both in terms of complication rate and patient reported outcome. All of the
      patients invited to participate in this study has been evaluated by experienced breast and
      plastic surgeons to be best suited with an immediate breast reconstruction with implant and
      ADM. The two types of ADMs evaluated in the study have shown good results in previous
      studies. As it is not expected that one of the tested ADMs is significantly better than the
      other, there is no predictable benefit for the individual patient in regards to participating
      in the study.
    

Intervention name(s): SurgiMend® Acellular Dermal Matrix; Strattice™ Acellular Dermal Matrix
Intervention type(s): Device; Device
Intervention description(s): See arm description.; See arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acelullar Dermal Matrix; Immediate Breast Reconstruction; Breast Implant