Trial Outcomes & Findings for The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe (NCT NCT01389232)
NCT ID: NCT01389232
Last Updated: 2021-06-21
Results Overview
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Month 6
Results posted on
2021-06-21
Participant Flow
Enrollment was defined as having signed the IRB-approved Informed Consent Form. 104 participants were enrolled, of which 100 were implanted with SERI® Surgical Scaffold and are presented in the participant flow.
Participant milestones
| Measure |
SeriScaffold® Surgical Scaffold
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
SeriScaffold® Surgical Scaffold
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
|---|---|
|
Overall Study
Had scaffold removed
|
15
|
|
Overall Study
Personal reasons
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Baseline characteristics by cohort
| Measure |
SeriScaffold® Surgical Scaffold
n=100 Participants
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: All participants with a Month 6 visit. 12 subjects exited the study prior to Month 6.
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Outcome measures
| Measure |
SeriScaffold® Surgical Scaffold
n=88 Participants
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Difficult to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Neither Difficult Nor Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Very Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Not Done
Implanted participants on whom procedure was reported "not done"
|
|---|---|---|---|---|---|---|
|
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
|
8.8 Scores on a Scale
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3, Month 12, Month 18, Month 24Population: All participants with a visit at the designated time point
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Outcome measures
| Measure |
SeriScaffold® Surgical Scaffold
n=89 Participants
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Difficult to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Neither Difficult Nor Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Very Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Not Done
Implanted participants on whom procedure was reported "not done"
|
|---|---|---|---|---|---|---|
|
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Month 3 (N=89)
|
8.6 Scores on a Scale
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Month 12 (N=83)
|
8.8 Scores on a Scale
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Month 18 (N=79)
|
8.8 Scores on a Scale
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
|
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Month 24 (N=80)
|
9.0 Scores on a Scale
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately Following Stage 1 SurgeryPopulation: All implanted participants. "Scaffold cutting and sharping before implantation" was reported "Not done" on n=50
Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use.
Outcome measures
| Measure |
SeriScaffold® Surgical Scaffold
n=100 Participants
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Difficult to Use
n=100 Participants
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Neither Difficult Nor Easy to Use
n=100 Participants
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Easy to Use
n=100 Participants
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Very Easy to Use
n=100 Participants
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Not Done
n=100 Participants
Implanted participants on whom procedure was reported "not done"
|
|---|---|---|---|---|---|---|
|
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Scaffold preparation before implantation
|
0 Participants
|
0 Participants
|
3 Participants
|
20 Participants
|
77 Participants
|
0 Participants
|
|
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Scaffold cutting and shaping before implantation
|
0 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
38 Participants
|
50 Participants
|
|
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Scaffold positioning/drapability during implant
|
0 Participants
|
0 Participants
|
37 Participants
|
14 Participants
|
49 Participants
|
0 Participants
|
|
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Scaffold cutting and shaping after implantation
|
0 Participants
|
1 Participants
|
35 Participants
|
12 Participants
|
52 Participants
|
0 Participants
|
|
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Scaffold suturing during implantation
|
0 Participants
|
1 Participants
|
37 Participants
|
14 Participants
|
48 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24Population: All implanted breasts evaluated at the designated time point
Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold.
Outcome measures
| Measure |
SeriScaffold® Surgical Scaffold
n=149 Breasts
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Difficult to Use
n=149 Breasts
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Neither Difficult Nor Easy to Use
n=149 Breasts
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Easy to Use
n=149 Breasts
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Very Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Not Done
Implanted participants on whom procedure was reported "not done"
|
|---|---|---|---|---|---|---|
|
Breast Anatomy Measurements
Preoperative
|
21.3 Centimeters (cm)
Interval 20.9 to 21.7
|
24.1 Centimeters (cm)
Interval 23.7 to 24.4
|
7.1 Centimeters (cm)
Interval 6.9 to 7.2
|
14.6 Centimeters (cm)
Interval 14.3 to 14.9
|
—
|
—
|
|
Breast Anatomy Measurements
First Postoperative
|
19.0 Centimeters (cm)
Interval 18.7 to 19.2
|
22.6 Centimeters (cm)
Interval 22.3 to 22.8
|
8.1 Centimeters (cm)
Interval 7.9 to 8.2
|
14.5 Centimeters (cm)
Interval 14.3 to 14.8
|
—
|
—
|
|
Breast Anatomy Measurements
Month 3
|
19.0 Centimeters (cm)
Interval 18.8 to 19.3
|
22.7 Centimeters (cm)
Interval 22.4 to 23.0
|
8.1 Centimeters (cm)
Interval 7.9 to 8.3
|
14.2 Centimeters (cm)
Interval 14.0 to 14.4
|
—
|
—
|
|
Breast Anatomy Measurements
Month 6
|
19.2 Centimeters (cm)
Interval 18.9 to 19.5
|
23.0 Centimeters (cm)
Interval 22.7 to 23.2
|
8.1 Centimeters (cm)
Interval 7.9 to 8.3
|
14.1 Centimeters (cm)
Interval 13.8 to 14.3
|
—
|
—
|
|
Breast Anatomy Measurements
Month 12
|
19.2 Centimeters (cm)
Interval 18.9 to 19.4
|
23.0 Centimeters (cm)
Interval 22.7 to 23.3
|
8.0 Centimeters (cm)
Interval 7.8 to 8.1
|
14.0 Centimeters (cm)
Interval 13.7 to 14.3
|
—
|
—
|
|
Breast Anatomy Measurements
Month 18
|
19.0 Centimeters (cm)
Interval 18.7 to 19.3
|
22.9 Centimeters (cm)
Interval 22.5 to 23.2
|
8.0 Centimeters (cm)
Interval 7.8 to 8.1
|
13.7 Centimeters (cm)
Interval 13.5 to 14.0
|
—
|
—
|
|
Breast Anatomy Measurements
Month 24
|
19.0 Centimeters (cm)
Interval 18.7 to 19.3
|
22.9 Centimeters (cm)
Interval 22.6 to 23.2
|
8.1 Centimeters (cm)
Interval 7.9 to 8.3
|
13.8 Centimeters (cm)
Interval 13.5 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24Population: All implanted breasts evaluated at the designated time point. Data was not available for 1 subject (both breasts) at baseline, 1 subject (right breast) at Month 6, 2 subjects (right breast) at Month 18 and 1 subject (right breast) at Month 24.
Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.
Outcome measures
| Measure |
SeriScaffold® Surgical Scaffold
n=146 Breasts
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Difficult to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Neither Difficult Nor Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Ease of Use During Surgery = Very Easy to Use
Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
Not Done
Implanted participants on whom procedure was reported "not done"
|
|---|---|---|---|---|---|---|
|
Subject Satisfaction With Breasts on a 5-Point Scale
Baseline (Missing=0)
|
3.7 Scores on a Scale
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Breasts on a 5-Point Scale
Month 6 (Missing=0)
|
4.3 Scores on a Scale
Standard Deviation 0.9
|
—
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Breasts on a 5-Point Scale
Month 12 (Missing=1)
|
4.4 Scores on a Scale
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Breasts on a 5-Point Scale
Month 18 (Missing=2)
|
4.4 Scores on a Scale
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Breasts on a 5-Point Scale
Month 24 (Missing=0)
|
4.4 Scores on a Scale
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SeriScaffold® Surgical Scaffold
Serious events: 53 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SeriScaffold® Surgical Scaffold
n=100 participants at risk
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Capsular contracture associated with breast implant
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Device extrusion
|
5.0%
5/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Pyrexia
|
3.0%
3/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Mastitis
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Neutropenic sepsis
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Wound infection
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Seroma
|
3.0%
3/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Investigations
Physical examination abnormal
|
3.0%
3/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
3.0%
3/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
2/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
6.0%
6/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Vascular disorders
Haematoma
|
3.0%
3/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Device Dislocation
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Inflammation
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Medical Device Complication
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Device Related Infection
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Endometritis
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Staphylococcal Infection
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Fractured Sacrum
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Breast Neoplasm
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
intraductal Proliferative Breast Lesion
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Spine
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta Previa
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
1.0%
1/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
Other adverse events
| Measure |
SeriScaffold® Surgical Scaffold
n=100 participants at risk
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
|
|---|---|
|
General disorders
Capsular contracture associated with breast implant
|
7.0%
7/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Device dislocation
|
5.0%
5/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Device extrusion
|
9.0%
9/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Impaired healing
|
5.0%
5/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Implant site reaction
|
6.0%
6/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
General disorders
Pyrexia
|
9.0%
9/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Gastroenteritis
|
6.0%
6/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
14/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Seroma
|
30.0%
30/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
9.0%
9/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Investigations
Physical examination abnormal
|
8.0%
8/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Nervous system disorders
Headache
|
12.0%
12/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Reproductive system and breast disorders
Breast pain
|
14.0%
14/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.0%
18/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
21.0%
21/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
|
Vascular disorders
Haematoma
|
7.0%
7/100
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER