Clinical trial NCT01256502: The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Sofregen Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery
timeFrame: Immediately following Stage I surgery
measure: Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points
timeFrame: Stage 2 Surgery, Months 12, 18 and 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
Study officials:
affiliation: Allergan Medical
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.