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

• Sponsor: Sofregen Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01256502
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction	Device: SERI® Surgical Scaffold	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Implanted Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.	Device: SERI® Surgical Scaffold; Breast reconstruction surgery

Outcome Measures

Primary Outcome Measures

1. Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months [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.

Secondary Outcome Measures

1. Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery [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.

2. Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

To be eligible for enrollment, the subject must:

• Be female, greater or equal to 18 years of age

• Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant

• Have previously had or 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:

The subject must not:

• 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 collagen-vascular, connective disease, or bleeding disorders

• Have a Body Mass Index (BMI) that is greater than or equal to 35

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

• Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer

• Have smoked within the last 12 months

• Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit

• Be pregnant, lactating, or expecting to be within the next 24 months

• Have concomitant unrelated condition of breast/chest wall/skin

• Have an abscess or infection at the time of surgery

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States

Sponsors and Collaborators

• Sofregen Medical, Inc.

Investigators

• Study Director: Medical Monitor, Allergan Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sofregen Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01256502
• Other Study ID Numbers: SURE-001
• First Posted: Dec 8, 2010
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Implanted Participants
Arm/Group Description	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Period Title: Overall Study
STARTED	139
COMPLETED	129
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Implanted Participants
Arm/Group Description	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Overall Participants	139
Age, Customized (participants) [Number]
18 to 19 years	0 0%
20 to 29 years	4 2.9%
30 to 39 years	15 10.8%
40 to 49 years	54 38.8%
50 to 59 years	40 28.8%
60 to 69 years	22 15.8%
70+ years	4 2.9%
Sex: Female, Male (Count of Participants)
Female	139 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	139 100%

Outcome Measures

1. Primary Outcome

Title	Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Implanted Participants
Arm/Group Description	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Measure Participants	134
Mean (Standard Deviation) [units on a scale]	9.4 (0.84)

2. Secondary Outcome

Title	Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery
Description	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.
Time Frame	Immediately following Stage I surgery

Outcome Measure Data

Analysis Population Description

Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.

Arm/Group Title	Very Difficult to Use	Difficult to Use	Neither Difficult Nor Easy to Use	Easy to Use	Very Easy to Use
Arm/Group Description
Measure Participants	139	139	139	139	139
SERI® preparation before implantation	0 0%	0 NaN	0 NaN	15 NaN	124 NaN
SERI® cutting and shaping before implantation	0 0%	0 NaN	0 NaN	18 NaN	121 NaN
SERI® positioning/drapability during implantation	0 0%	0 NaN	2 NaN	61 NaN	76 NaN
SERI® cutting and shaping after implantation	0 0%	0 NaN	0 NaN	47 NaN	92 NaN
SERI® suturing during implantation	0 0%	0 NaN	1 NaN	53 NaN	85 NaN

3. Secondary Outcome

Title	Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points
Description	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.
Time Frame	Stage 2 Surgery, Months 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Implanted Participants
Arm/Group Description	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
Measure Participants	134
Stage 2 Surgery (n=202 breasts)	9.3 (1.25)
Month 12 (n=198 breasts)	9.5 (0.89)
Month 18 (n=199 breasts)	9.4 (1.26)
Month 24 (n=195 breasts)	9.5 (1.01)

Adverse Events

Time Frame	Up to 24 months following SERI implantation
Adverse Event Reporting Description	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.
Arm/Group Title	Implanted Participants
Arm/Group Description	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
All Cause Mortality
	Implanted Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Implanted Participants
	Affected / at Risk (%)	# Events
Total	25/139 (18%)
Cardiac disorders
Atrial fibrillation	1/139 (0.7%)
Cardiomyopathy	1/139 (0.7%)
Pericarditis constrictive	1/139 (0.7%)
Gastrointestinal disorders
Salivary gland calculus	1/139 (0.7%)
Small intestinal obstruction	1/139 (0.7%)
General disorders
Capsular contracture associated with breast implant	3/139 (2.2%)
Implant site reaction	1/139 (0.7%)
Infections and infestations
Cellulitis	5/139 (3.6%)
Device related infection	2/139 (1.4%)
Breast cellulitis	1/139 (0.7%)
Pneumonia	2/139 (1.4%)
Pharyngitis	1/139 (0.7%)
Pharyngitis streptococcal	1/139 (0.7%)
Vaginal cellulitis	1/139 (0.7%)
Parotitis	1/139 (0.7%)
Mastitis	2/139 (1.4%)
Postoperative wound infection	1/139 (0.7%)
Injury, poisoning and procedural complications
Seroma	1/139 (0.7%)
Wound dehiscence	1/139 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lobular breast carcinoma in situ	1/139 (0.7%)
Metastases to liver	1/139 (0.7%)
Metastases to spleen	1/139 (0.7%)
Pancreatic carcinoma metastatic	1/139 (0.7%)
Breast cancer	3/139 (2.2%)
Breast cancer recurrent	2/139 (1.4%)
Metastases to lymph nodes	1/139 (0.7%)
Metastases to bone	1/139 (0.7%)
Nervous system disorders
Hemiparesis	1/139 (0.7%)
Pregnancy, puerperium and perinatal conditions
Abortion missed	1/139 (0.7%)
Reproductive system and breast disorders
Vaginal ulceration	1/139 (0.7%)
Vascular disorders
Deep vein thrombosis	1/139 (0.7%)
Hematoma	1/139 (0.7%)
Other (Not Including Serious) Adverse Events
	Implanted Participants
	Affected / at Risk (%)	# Events
Total	107/139 (77%)
Gastrointestinal disorders
Nausea	7/139 (5%)
General disorders
Breast complication associated with device	12/139 (8.6%)
Capsular contracture associated with breast implant	10/139 (7.2%)
Injury, poisoning and procedural complications
Procedural pain	19/139 (13.7%)
Seroma	13/139 (9.4%)
Wound dehiscence	9/139 (6.5%)
Psychiatric disorders
Insomnia	9/139 (6.5%)
Skin and subcutaneous tissue disorders
Erythema	10/139 (7.2%)
Rash	10/139 (7.2%)
Skin necrosis	12/139 (8.6%)
Vascular disorders
Hematoma	9/139 (6.5%)

Limitations/Caveats

None to report.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.