The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256502
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : May 16, 2014
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Sofregen Medical, Inc.

Brief Summary:
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Device: SERI® Surgical Scaffold Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Implanted Participants
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Device: SERI® Surgical Scaffold
Breast reconstruction surgery

Primary Outcome Measures :
  1. Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months [ Time Frame: 6 months ]
    The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.

Secondary Outcome Measures :
  1. Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery [ Time Frame: Immediately following Stage I surgery ]
    Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.

  2. Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points [ Time Frame: Stage 2 Surgery, Months 12, 18 and 24 ]
    Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be eligible for enrollment, the subject must:

  • Be female, greater or equal to 18 years of age
  • Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
  • Have previously had or be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
  • Be in good health other than breast pathology and be suited to general anesthesia and planned treatments.

Exclusion Criteria:

The subject must not:

  • Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
  • Have a known allergy to silk
  • Have collagen-vascular, connective disease, or bleeding disorders
  • Have a Body Mass Index (BMI) that is greater than or equal to 35
  • Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
  • Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer
  • Have smoked within the last 12 months
  • Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
  • Be pregnant, lactating, or expecting to be within the next 24 months
  • Have concomitant unrelated condition of breast/chest wall/skin
  • Have an abscess or infection at the time of surgery
  • Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
  • Have had a prior soft tissue support device implanted in the breast
  • Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256502

United States, California
Los Angeles, California, United States
Sponsors and Collaborators
Sofregen Medical, Inc.
Study Director: Medical Monitor Allergan Medical

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sofregen Medical, Inc. Identifier: NCT01256502     History of Changes
Other Study ID Numbers: SURE-001
First Posted: December 8, 2010    Key Record Dates
Results First Posted: May 16, 2014
Last Update Posted: November 6, 2017
Last Verified: October 2017