N/A
N=100
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Soft Tissue Support and Repair
Bottom Line
View on ClinicalTrials.gov: NCT01389232 ↗Enrolled (actual)
100
Serious AEs
53.0%
Results posted
Jun 2021
Primary outcome: Primary: Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale — 8.8 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SeriScaffold® Surgical Scaffold (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sofregen Medical, Inc.
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale |
8.6; 8.8; 8.8; 9.0 | — |
| SECONDARY Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale |
8.6; 8.8; 8.8; 9.0 | — |
| SECONDARY Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale |
0; 0; 3; 20; 77; 0 | — |
| SECONDARY Breast Anatomy Measurements |
21.3; 24.1; 7.1; 14.6; 19.0; 22.6 | — |
| SECONDARY Subject Satisfaction With Breasts on a 5-Point Scale |
3.7; 4.3; 4.4; 4.4; 4.4 | — |
Summary
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01389232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.