Trial Outcomes & Findings for PleuraSeal Post Market Study (Europe) (NCT NCT00704171)

NCT ID: NCT00704171

Last Updated: 2016-10-27

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

121 participants

Primary outcome timeframe

30 days

Results posted on

2016-10-27

Participant Flow

Between January 28, 2008 and October 21, 2008, a total of 161 subjects were consented and screened for potential study participation at 8 institutions (hospitals). Of these subjects, 121 were randomized.

Subjects were evaluated for pre-operative and intra-operative eligibility criteria. Randomization occurred intra-operatively.

Participant milestones

Participant milestones
Measure	PleuraSeal PleuraSeal Lung Sealant System	Standard of Care Standard tissue closure techniques (control) - sutures or staples only
Overall Study STARTED	62	59
Overall Study COMPLETED	61	59
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PleuraSeal PleuraSeal Lung Sealant System	Standard of Care Standard tissue closure techniques (control) - sutures or staples only
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

PleuraSeal Post Market Study (Europe)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only	Total n=121 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 9.1 • n=5 Participants	62.8 years STANDARD_DEVIATION 10.8 • n=7 Participants	62.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	61 participants n=5 Participants	55 participants n=7 Participants	116 participants n=5 Participants
Race/Ethnicity, Customized African	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Netherlands	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Austria	32 participants n=5 Participants	30 participants n=7 Participants	62 participants n=5 Participants
Region of Enrollment Switzerland	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Nicotine Use History	31 participants n=5 Participants	34 participants n=7 Participants	65 participants n=5 Participants
Nicotine Use Current	22 participants n=5 Participants	17 participants n=7 Participants	39 participants n=5 Participants
Nicotine Use Never	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants
Body Mass Index	25.86 kg/m^2 STANDARD_DEVIATION 4.73 • n=5 Participants	26.35 kg/m^2 STANDARD_DEVIATION 4.55 • n=7 Participants	26.10 kg/m^2 STANDARD_DEVIATION 4.63 • n=5 Participants
Height	169.5 cm STANDARD_DEVIATION 8.8 • n=5 Participants	169.4 cm STANDARD_DEVIATION 9.6 • n=7 Participants	169.4 cm STANDARD_DEVIATION 9.1 • n=5 Participants
Weight	74.46 kg STANDARD_DEVIATION 15.35 • n=5 Participants	75.57 kg STANDARD_DEVIATION 13.96 • n=7 Participants	75.00 kg STANDARD_DEVIATION 14.64 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only
Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.	41.9 Percentage of participants	30.5 Percentage of participants

PRIMARY outcome

Timeframe: 30 days

Population: Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.

Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles

Outcome measures

Outcome measures
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only
Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge Grade 1 air leak	37.5 Percentage of participants	50 Percentage of participants
Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge Grade 2/3 air leak	43.5 Percentage of participants	15.2 Percentage of participants

SECONDARY outcome

Timeframe: Intra-operatively, time of study procedure

Success is defined as no presence of air leak intra-operatively.

Outcome measures

Outcome measures
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only
Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.	71 Percentage of participants	23.7 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only
Time From Skin Closure to Last Observable Air Leak.	6.0 hours Interval 0.0 to 30.0	30.0 hours Interval 6.0 to 30.0

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only
Duration of Chest Drainage	93.68 hours Standard Deviation 127.88	94.05 hours Standard Deviation 81.05

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	PleuraSeal n=62 Participants PleuraSeal Lung Sealant System	Standard of Care n=59 Participants Standard tissue closure techniques (control) - sutures or staples only
Duration of Hospitalization	312.0 hours Standard Deviation 419.2	288.0 hours Standard Deviation 254.1

Adverse Events

PleuraSeal

Serious events: 16 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard of Care

Serious events: 11 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PleuraSeal n=62 participants at risk PleuraSeal Lung Sealant System	Standard of Care n=59 participants at risk Standard tissue closure techniques (control) - sutures or staples only
Cardiac disorders Atrial Fibrillation	3.2% 2/62 • Number of events 2 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	6.8% 4/59 • Number of events 4 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).

Additional Information

Jennifer L. Doyle, Global Director of Clinical Affairs

Covidien

Phone: 781-839-1770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution and Investigator agree to submit the draft of any proposed publication to Sponsor at least 30 dyas prior to submission for publication, presentation, or use, and agrees, at the request of the Sponsor, to withhold any such submission for an additional period, not to exceed 90 days to allow Sponsor to file patent applications. The first publication of the results shall be made in conjunction with the presentation of a joint, multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	PleuraSeal n=62 participants at risk PleuraSeal Lung Sealant System	Standard of Care n=59 participants at risk Standard tissue closure techniques (control) - sutures or staples only
Cardiac disorders Cardiac Arrest	0.00% 0/62 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Cardiac disorders Cardiac Failure Chronic	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Cardiac disorders Ventricular Fibrillation	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
General disorders Fatigue	0.00% 0/62 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	3.4% 2/59 • Number of events 2 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
General disorders Pain	3.2% 2/62 • Number of events 2 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Infections and infestations Bronchopneumonia	0.00% 0/62 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Infections and infestations Empyema	3.2% 2/62 • Number of events 2 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Infections and infestations Pneumonia	3.2% 2/62 • Number of events 2 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Infections and infestations Wound Infection	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Nervous system disorders Ischaemic Stroke	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/62 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Bronchopleural Fistula	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Emphysema	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	3.4% 2/59 • Number of events 2 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Pneumothorax	8.1% 5/62 • Number of events 5 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/62 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	1.6% 1/62 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	0.00% 0/59 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).
Vascular disorders Peripheral Ischaemia	0.00% 0/62 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).	1.7% 1/59 • Number of events 1 • Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively. Events deemed probable, possible, or definitely related to treatment (PleuraSeal or Control) were to be followed until resolution or 60 days following end of study (whichever comes first).