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PleuraSeal Post Market Study (Europe)

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ClinicalTrials.gov Identifier: NCT00704171
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : March 15, 2010
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Lung Disease
Pulmonary Lobectomy
Interventions Procedure: Standard Tissue Closure Techniques
Device: PleuraSeal Lung Sealant System
Enrollment 121
Recruitment Details 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.
Pre-assignment Details Subjects were evaluated for pre-operative and intra-operative eligibility criteria. Randomization occurred intra-operatively.
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description PleuraSeal Lung Sealant System Standard tissue closure techniques (control) - sutures or staples only
Period Title: Overall Study
Started 62 59
Completed 61 [1] 59 [2]
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
One subject withdrew consent prior to study completion. No reason given.
[2]
All control subjects completed the study.
Arm/Group Title PleuraSeal Standard of Care Total
Hide Arm/Group Description PleuraSeal Lung Sealant System Standard tissue closure techniques (control) - sutures or staples only Total of all reporting groups
Overall Number of Baseline Participants 62 59 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 59 participants 121 participants
61.5  (9.1) 62.8  (10.8) 62.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Female
26
  41.9%
22
  37.3%
48
  39.7%
Male
36
  58.1%
37
  62.7%
73
  60.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 62 participants 59 participants 121 participants
Caucasian 61 55 116
African 0 1 1
Asian 0 1 1
Hispanic 0 1 1
Other 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 62 participants 59 participants 121 participants
Netherlands 9 6 15
Belgium 14 14 28
United Kingdom 6 4 10
Austria 32 30 62
Switzerland 1 5 6
Nicotine Use  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 62 participants 59 participants 121 participants
History 31 34 65
Current 22 17 39
Never 9 8 17
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 62 participants 59 participants 121 participants
25.86  (4.73) 26.35  (4.55) 26.10  (4.63)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 62 participants 59 participants 121 participants
169.5  (8.8) 169.4  (9.6) 169.4  (9.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 62 participants 59 participants 121 participants
74.46  (15.35) 75.57  (13.96) 75.00  (14.64)
1.Primary Outcome
Title Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description:
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: Percentage of participants
41.9 30.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge
Hide Description Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description:
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: Percentage of participants
Grade 1 air leak 37.5 50
Grade 2/3 air leak 43.5 15.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments For subgroup with pre-randomization air leak grade of 1
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .013
Comments For subgroup with pre-randomization air leak grade of 2 or 3
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.
Hide Description Success is defined as no presence of air leak intra-operatively.
Time Frame Intra-operatively, time of study procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description:
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: Percentage of participants
71 23.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments two-sided
4.Secondary Outcome
Title Time From Skin Closure to Last Observable Air Leak.
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description:
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Overall Number of Participants Analyzed 62 59
Median (95% Confidence Interval)
Unit of Measure: hours
6.0
(0.0 to 30.0)
30.0
(6.0 to 30.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.790
Comments [Not Specified]
Method Kaplan-Meier
Comments Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.
5.Secondary Outcome
Title Duration of Chest Drainage
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description:
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Overall Number of Participants Analyzed 62 59
Median (Standard Deviation)
Unit of Measure: hours
93.68  (127.88) 94.05  (81.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.559
Comments [Not Specified]
Method 2-sample t-test
Comments [Not Specified]
6.Secondary Outcome
Title Duration of Hospitalization
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description:
PleuraSeal Lung Sealant System
Standard tissue closure techniques (control) - sutures or staples only
Overall Number of Participants Analyzed 62 59
Median (Standard Deviation)
Unit of Measure: hours
312.0  (419.2) 288.0  (254.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PleuraSeal, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.292
Comments [Not Specified]
Method 2-sample t-test
Comments [Not Specified]
Time Frame Adverse events were collected from time of randomization until completion of the study, 30 days postoperatively.
Adverse Event Reporting Description 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).
 
Arm/Group Title PleuraSeal Standard of Care
Hide Arm/Group Description PleuraSeal Lung Sealant System Standard tissue closure techniques (control) - sutures or staples only
All-Cause Mortality
PleuraSeal Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PleuraSeal Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/62 (25.81%)      11/59 (18.64%)    
Cardiac disorders     
Cardiac Arrest † 1  0/62 (0.00%)  0 1/59 (1.69%)  1
Cardiac Failure Chronic † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Ventricular Fibrillation † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
General disorders     
Fatigue † 1  0/62 (0.00%)  0 2/59 (3.39%)  2
Pain † 1  2/62 (3.23%)  2 0/59 (0.00%)  0
Infections and infestations     
Bronchopneumonia † 1  0/62 (0.00%)  0 1/59 (1.69%)  1
Empyema † 1  2/62 (3.23%)  2 0/59 (0.00%)  0
Pneumonia † 1  2/62 (3.23%)  2 1/59 (1.69%)  1
Wound Infection † 1  1/62 (1.61%)  1 1/59 (1.69%)  1
Nervous system disorders     
Ischaemic Stroke † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Atelectasis † 1  0/62 (0.00%)  0 1/59 (1.69%)  1
Bronchopleural Fistula † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Emphysema † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Hydropneumothorax † 1  1/62 (1.61%)  1 2/59 (3.39%)  2
Pleural Effusion † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Pneumothorax † 1  5/62 (8.06%)  5 1/59 (1.69%)  1
Pulmonary Embolism † 1  0/62 (0.00%)  0 1/59 (1.69%)  1
Skin and subcutaneous tissue disorders     
Subcutaneous Emphysema † 1  1/62 (1.61%)  1 0/59 (0.00%)  0
Vascular disorders     
Peripheral Ischaemia † 1  0/62 (0.00%)  0 1/59 (1.69%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PleuraSeal Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/62 (3.23%)      4/59 (6.78%)    
Cardiac disorders     
Atrial Fibrillation † 1  2/62 (3.23%)  2 4/59 (6.78%)  4
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, no source vocabulary
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Jennifer L. Doyle, Global Director of Clinical Affairs
Organization: Covidien
Phone: 781-839-1770
Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00704171     History of Changes
Other Study ID Numbers: LUN-06-002
First Submitted: June 23, 2008
First Posted: June 24, 2008
Results First Submitted: December 21, 2009
Results First Posted: March 15, 2010
Last Update Posted: October 27, 2016