Trial Outcomes & Findings for The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery (NCT NCT01256502)

Last Updated: 2017-11-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

6 months

Results posted on

2017-11-06

Participant Flow

Enrollment was defined as having signed the IRB-approved Informed Consent Form. 160 patients were enrolled, of which 139 were implanted with SERI® Surgical Scaffold.

Participant milestones

Participant milestones
Measure	Implanted Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Overall Study STARTED	139
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Implanted Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Overall Study Had scaffold removed	4
Overall Study Personal reasons	5
Overall Study Protocol deviation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implanted Participants n=139 Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Age, Customized 18 to 19 years	0 participants n=5 Participants
Age, Customized 20 to 29 years	4 participants n=5 Participants
Age, Customized 30 to 39 years	15 participants n=5 Participants
Age, Customized 40 to 49 years	54 participants n=5 Participants
Age, Customized 50 to 59 years	40 participants n=5 Participants
Age, Customized 60 to 69 years	22 participants n=5 Participants
Age, Customized 70+ years	4 participants n=5 Participants
Sex: Female, Male Female	139 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	139 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.

Outcome measures

Outcome measures
Measure	Implanted Participants n=134 Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.	Difficult to Use	Neither Difficult Nor Easy to Use	Easy to Use	Very Easy to Use
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months	9.4 units on a scale Standard Deviation 0.84	—	—	—	—

SECONDARY outcome

Timeframe: Immediately following Stage I surgery

Population: Full analysis population included all enrolled participants who had SERI® Placement during 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.

Outcome measures

Outcome measures
Measure	Implanted Participants n=139 Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.	Difficult to Use n=139 Participants	Neither Difficult Nor Easy to Use n=139 Participants	Easy to Use n=139 Participants	Very Easy to Use n=139 Participants
Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery SERI® preparation before implantation	0 participants	0 participants	0 participants	15 participants	124 participants
Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery SERI® cutting and shaping before implantation	0 participants	0 participants	0 participants	18 participants	121 participants
Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery SERI® positioning/drapability during implantation	0 participants	0 participants	2 participants	61 participants	76 participants
Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery SERI® cutting and shaping after implantation	0 participants	0 participants	0 participants	47 participants	92 participants
Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery SERI® suturing during implantation	0 participants	0 participants	1 participants	53 participants	85 participants

SECONDARY outcome

Timeframe: Stage 2 Surgery, Months 12, 18 and 24

Population: Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.

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.

Outcome measures

Outcome measures
Measure	Implanted Participants n=134 Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.	Difficult to Use	Neither Difficult Nor Easy to Use	Easy to Use	Very Easy to Use
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points Stage 2 Surgery (n=202 breasts)	9.3 units on a scale Standard Deviation 1.25 • Interval 9.06 to 9.47	—	—	—	—
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points Month 12 (n=198 breasts)	9.5 units on a scale Standard Deviation 0.89 • Interval 9.34 to 9.62	—	—	—	—
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points Month 18 (n=199 breasts)	9.4 units on a scale Standard Deviation 1.26 • Interval 9.13 to 9.56	—	—	—	—
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points Month 24 (n=195 breasts)	9.5 units on a scale Standard Deviation 1.01 • Interval 9.41 to 9.72	—	—	—	—

Adverse Events

Implanted Participants

Serious events: 25 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Implanted Participants n=139 participants at risk Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Infections and infestations Cellulitis	3.6% 5/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Device related infection	1.4% 2/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Injury, poisoning and procedural complications Seroma	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Breast cellulitis	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Injury, poisoning and procedural complications Wound dehiscence	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Pneumonia	1.4% 2/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lobular breast carcinoma in situ	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Vascular disorders Deep vein thrombosis	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Pharyngitis	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Pharyngitis streptococcal	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Vaginal cellulitis	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Reproductive system and breast disorders Vaginal ulceration	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Parotitis	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Gastrointestinal disorders Salivary gland calculus	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spleen	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Cardiac disorders Atrial fibrillation	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Cardiac disorders Cardiomyopathy	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Cardiac disorders Pericarditis constrictive	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Gastrointestinal disorders Small intestinal obstruction	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
General disorders Capsular contracture associated with breast implant	2.2% 3/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
General disorders Implant site reaction	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Mastitis	1.4% 2/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Infections and infestations Postoperative wound infection	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.2% 3/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	1.4% 2/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Nervous system disorders Hemiparesis	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Vascular disorders Hematoma	0.72% 1/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.

Other adverse events

Other adverse events
Measure	Implanted Participants n=139 participants at risk Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Injury, poisoning and procedural complications Procedural pain	13.7% 19/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Gastrointestinal disorders Nausea	5.0% 7/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
General disorders Breast complication associated with device	8.6% 12/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
General disorders Capsular contracture associated with breast implant	7.2% 10/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Injury, poisoning and procedural complications Seroma	9.4% 13/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Injury, poisoning and procedural complications Wound dehiscence	6.5% 9/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Psychiatric disorders Insomnia	6.5% 9/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Skin and subcutaneous tissue disorders Erythema	7.2% 10/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Skin and subcutaneous tissue disorders Rash	7.2% 10/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Skin and subcutaneous tissue disorders Skin necrosis	8.6% 12/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.
Vascular disorders Hematoma	6.5% 9/139 • Up to 24 months following SERI implantation All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \>5% frequency are reported. Individual participants can experience more than 1 AE.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.
Publication restrictions are in place

Restriction type: OTHER