Completed

NCT Number: NCT01389232

The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe

This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.

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Key information

Conditions

Soft Tissue Support and Repair

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Düsseldorf, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Be female, greater or equal to 18 years of age
Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
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

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 any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
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

SeriScaffold® Surgical Scaffold

Device

A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair

Primary outcomes

Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale

Time frame: Month 6

Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.

Secondary outcomes

Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale

Time frame: Month 3, Month 12, Month 18, Month 24

Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale

Time frame: Immediately Following Stage 1 Surgery

Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use.
Breast Anatomy Measurements

Time frame: Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24

Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold.
Subject Satisfaction With Breasts on a 5-Point Scale

Time frame: Baseline, Month 6, Month 12, Month 18, Month 24

Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.

Sponsors and collaborators

Lead sponsor

Sofregen Medical, Inc.

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2015
First posted: Jul 8, 2011
Registry last updated: Jun 21, 2021

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.