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

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.

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Key information

Conditions

Breast Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SERI® Surgical Scaffold

Device

Breast reconstruction surgery

Primary outcomes

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Sofregen Medical, Inc.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2014
First posted: Dec 8, 2010
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed