Trial Outcomes & Findings for Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection (NCT NCT02491671)
NCT ID: NCT02491671
Last Updated: 2021-08-09
Results Overview
Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
From day of surgery to the fifth postoperative day
Results posted on
2021-08-09
Participant Flow
Participant milestones
| Measure |
Experimental Group
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
131
|
|
Overall Study
COMPLETED
|
118
|
118
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Experimental Group
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
8
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Use of sealants other than Hemopatch
|
5
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=118 Participants
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
n=118 Participants
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.77 years
n=118 Participants
|
70.76 years
n=118 Participants
|
70.77 years
n=236 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=118 Participants
|
27 Participants
n=118 Participants
|
52 Participants
n=236 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=118 Participants
|
91 Participants
n=118 Participants
|
184 Participants
n=236 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
118 participants
n=118 Participants
|
118 participants
n=118 Participants
|
236 participants
n=236 Participants
|
|
Body Mass Index
|
24.5 kg/m^2
n=118 Participants
|
24.27 kg/m^2
n=118 Participants
|
24.4 kg/m^2
n=236 Participants
|
|
American Society of Anesthesiologists (ASA) classification
ASA 2
|
54 Participants
n=118 Participants
|
51 Participants
n=118 Participants
|
105 Participants
n=236 Participants
|
|
American Society of Anesthesiologists (ASA) classification
ASA 3
|
62 Participants
n=118 Participants
|
65 Participants
n=118 Participants
|
127 Participants
n=236 Participants
|
|
American Society of Anesthesiologists (ASA) classification
ASA 4
|
2 Participants
n=118 Participants
|
2 Participants
n=118 Participants
|
4 Participants
n=236 Participants
|
|
Type of Surgery
Segmentectomy
|
7 Participants
n=118 Participants
|
4 Participants
n=118 Participants
|
11 Participants
n=236 Participants
|
|
Type of Surgery
Lobectomy
|
106 Participants
n=118 Participants
|
107 Participants
n=118 Participants
|
213 Participants
n=236 Participants
|
|
Type of Surgery
Bilobectomy
|
5 Participants
n=118 Participants
|
7 Participants
n=118 Participants
|
12 Participants
n=236 Participants
|
PRIMARY outcome
Timeframe: From day of surgery to the fifth postoperative dayPrevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery
Outcome measures
| Measure |
Experimental Group
n=118 Participants
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
n=118 Participants
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Number of Participants With Prolonged Air Leak (PAL)
|
33 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Check everyday from day of surgery up to 38 days post-operative at maximumMeasured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators)
Outcome measures
| Measure |
Experimental Group
n=118 Participants
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
n=118 Participants
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Duration of Air Leaks
|
1 days
Interval 0.0 to 12.0
|
1 days
Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: From day of surgery up to 30 days thereafterRate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative.
Outcome measures
| Measure |
Experimental Group
n=118 Participants
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
n=118 Participants
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Number of Participants With at Least One Chest Tube Reinsertion
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 days post-operativeRate of readmissions due to relapsing pneumothorax (follow-up 30 days)
Outcome measures
| Measure |
Experimental Group
n=118 Participants
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
n=118 Participants
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Number of Participants With One or More Readmission
|
0 Participants
|
0 Participants
|
Adverse Events
Experimental Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 7 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental Group
n=118 participants at risk
Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures
|
Control Group
n=118 participants at risk
Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary. Mechanical ventilation
|
1.7%
2/118 • Number of events 2 • Through study completion, a total of up to 3 months.
|
3.4%
4/118 • Number of events 4 • Through study completion, a total of up to 3 months.
|
|
Injury, poisoning and procedural complications
Reoperation for bleeding
|
0.85%
1/118 • Number of events 1 • Through study completion, a total of up to 3 months.
|
2.5%
3/118 • Number of events 3 • Through study completion, a total of up to 3 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place