The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
|ClinicalTrials.gov Identifier: NCT01256502|
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : May 16, 2014
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Reconstruction||Device: SERI® Surgical Scaffold||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||April 2014|
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Device: SERI® Surgical Scaffold
Breast reconstruction surgery
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256502
|United States, California|
|Los Angeles, California, United States|
|Study Director:||Medical Monitor||Allergan Medical|