Trial Outcomes & Findings for SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery (NCT NCT02030938)

NCT ID: NCT02030938

Last Updated: 2021-12-28

Results Overview

This refers to the proportion of implanted breasts that will require reoperation for the recurrence of the initial cause of the increase in nipple to inframammary fold distance at the end of the 12-month follow-up period. Reoperation rate outcomes are presented as number of implanted breasts that required a reoperation out of the overall number of units analyzed.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

12 months

Results posted on

2021-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	SERI® Surgical Scaffold Implanted Breasts SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
Overall Study STARTED	34
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	SERI® Surgical Scaffold Implanted Breasts SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SERI® Surgical Scaffold Implanted Breasts n=34 Participants SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
Age, Continuous	44.4 years STANDARD_DEVIATION 13.37 • n=5 Participants
Sex/Gender, Customized Sex · Female - Child-bearing Potential	22 Participants n=5 Participants
Sex/Gender, Customized Sex · Female - Non Child-bearing Potential	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Skin Stretch n=34 Implanted breasts Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)	Fold Malposition n=22 Implanted breasts Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months.	0 Implanted breasts Interval 0.0 to 10.3	0 Implanted breasts Interval 0.0 to 15.4

SECONDARY outcome

Timeframe: 12 months

This refers to the proportion of implanted breasts that will require reoperation for any cause at the end of the 12 month follow up period. The outcome is presented as the number of implanted breasts that required reoperation from the overall number of units analyzed.

Outcome measures

Outcome measures
Measure	Skin Stretch n=56 Implanted breasts Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)	Fold Malposition Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months	1 Implanted breasts Interval 0.0 to 9.6	—

SECONDARY outcome

Timeframe: 30 days

This refers to the AE incidence rate per implanted breast at thirty days. Outcome is reported as the number of adverse events reported for the overall number of units analyzed.

Outcome measures

Outcome measures
Measure	Skin Stretch n=56 Implanted breasts Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)	Fold Malposition Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
AE Incidence Rates (Per Implanted Breast) at 30 Days	1 Adverse events Interval 0.0 to 9.6	—

SECONDARY outcome

Timeframe: 12 months

This refers to the AE incidence rate per implanted breast at twelve months. Outcome is reported as the number of adverse events reported for the overall number of units analyzed.

Outcome measures

Outcome measures
Measure	Skin Stretch n=56 Implanted breasts Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)	Fold Malposition Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
AE Incidence Rates (Per Implanted Breast) at 12 Months	3 Adverse events Interval 1.1 to 14.9	—

SECONDARY outcome

Timeframe: 12 months

Mammometry is defined as standardized breast measurements. Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging.

Outcome measures

Outcome measures
Measure	Skin Stretch n=54 Implanted breasts Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)	Fold Malposition n=54 Implanted breasts Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)	-1.42 cm Standard Deviation 7.06	-1.24 cm Standard Deviation 4.41

SECONDARY outcome

Timeframe: 12 months

The BREAST-Q is a self-administered questionnaire developed at the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. This instrument specifically measured subject satisfaction and health related quality of life (QoL) following different types of breast surgery (reconstruction,augmentation, reduction, and mastectomy only). A subset of 4 scales from the augmentation module (Satisfaction with breasts, Satisfaction with outcome, Psychosocial wellbeing and Sexual wellbeing) were used in this study. In accordance with the BREAST-Q manual, subject scores were transformed into linearized measurements on a 0 to 100 scale, using the QScore software which was developed based on the Rasch model. For the transformed scores, a higher score indicated greater satisfaction or higher function.

Outcome measures

Outcome measures
Measure	Skin Stretch n=29 Participants Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)	Fold Malposition Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)	34.8 units on a scale Standard Deviation 24.68	—

Adverse Events

SERI® Surgical Scaffold Implanted Breasts

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SERI® Surgical Scaffold Implanted Breasts n=34 participants at risk SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
General disorders Breast complication associated with device	2.9% 1/34 • Number of events 1 • Adverse event data was collected over 12 months

Other adverse events

Other adverse events
Measure	SERI® Surgical Scaffold Implanted Breasts n=34 participants at risk SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
Reproductive system and breast disorders Breast pain	8.8% 3/34 • Adverse event data was collected over 12 months
Reproductive system and breast disorders Breast mass	5.9% 2/34 • Adverse event data was collected over 12 months
Reproductive system and breast disorders Breast haematoma	2.9% 1/34 • Adverse event data was collected over 12 months
Reproductive system and breast disorders Breast swelling	2.9% 1/34 • Adverse event data was collected over 12 months
Injury, poisoning and procedural complications Procedural pain	2.9% 1/34 • Adverse event data was collected over 12 months
Injury, poisoning and procedural complications Suture rupture	2.9% 1/34 • Adverse event data was collected over 12 months
Investigations Physical breast examination abnormal	2.9% 1/34 • Adverse event data was collected over 12 months
Investigations Physical examination abnormal	2.9% 1/34 • Adverse event data was collected over 12 months
General disorders Breast complication associated with device	2.9% 1/34 • Adverse event data was collected over 12 months
Infections and infestations Incision site cellulitis	2.9% 1/34 • Adverse event data was collected over 12 months
Infections and infestations Mastitis	2.9% 1/34 • Adverse event data was collected over 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.9% 1/34 • Adverse event data was collected over 12 months
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/34 • Adverse event data was collected over 12 months
General disorders Fall	2.9% 1/34 • Adverse event data was collected over 12 months
Skin and subcutaneous tissue disorders Cutaneous contour deformity	2.9% 1/34 • Adverse event data was collected over 12 months

Additional Information

Clinical Project Manager

Sofregen

Phone: 4029991564

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place