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

NCT01256502 | Completed Results

• 1 other identifier: SURE-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 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.

  6 months

Secondary Outcomes (2)

• Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery

  Immediately following Stage I surgery

• Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points

  Stage 2 Surgery, Months 12, 18 and 24

Study Arms (1)

Implanted Participants

OTHER

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

Device: SERI® Surgical Scaffold

Interventions

SERI® Surgical Scaffold DEVICE

Breast reconstruction surgery

Implanted Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead

Study Sites (1)

Unknown Facility

Los Angeles, California, United States

Location

Related Publications (1)

• 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.

  PMID: 25502862 DERIVED

Limitations and Caveats

None to report.

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Monitor

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2014
• Last Updated: November 6, 2017
• Results First Posted: May 16, 2014

Record last verified: 2017-10

Locations

US (1)