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

NCT ID: NCT01256502

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Breast Reconstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implanted Participants

Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.

Group Type: OTHER

SERI® Surgical Scaffold

Intervention Type: DEVICE

Breast reconstruction surgery

Interventions

SERI® Surgical Scaffold

Breast reconstruction surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sofregen Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Allergan Medical

Locations

Los Angeles, California, United States

Countries

United States

References

Fine NA, Lehfeldt M, Gross JE, Downey S, Kind GM, Duda G, Kulber D, Horan R, Ippolito J, Jewell M. SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data. Plast Reconstr Surg. 2015 Feb;135(2):339-351. doi: 10.1097/PRS.0000000000000987.

Reference Type: DERIVED

PMID: 25502862 (View on PubMed)

Other Identifiers

SURE-001

Identifier Type: -

Identifier Source: org_study_id