Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®
1 other identifier
interventional
260
1 country
6
Brief Summary
The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2015
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedStudy Start
First participant enrolled
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedResults Posted
Study results publicly available
July 27, 2021
CompletedAugust 9, 2021
August 1, 2021
3.6 years
June 10, 2015
April 15, 2021
August 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Prolonged Air Leak (PAL)
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
From day of surgery to the fifth postoperative day
Secondary Outcomes (3)
Duration of Air Leaks
Check everyday from day of surgery up to 38 days post-operative at maximum
Number of Participants With at Least One Chest Tube Reinsertion
From day of surgery up to 30 days thereafter
Number of Participants With One or More Readmission
30 days post-operative
Study Arms (2)
Experimental group
EXPERIMENTALExperimental 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.
Control group
OTHERControl group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
Interventions
Eligibility Criteria
You may qualify if:
- Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy)
- Patients classified in class D according estimated risk of PAL
- Age between 18 and 80 years
You may not qualify if:
- Those patients that according to Investigator assessment are not going to tolerate the procedure
- Clinical and anesthetic criteria that contraindicate surgery
- Severe uncontrolled illness
- Pregnancy
- Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization.
- Lack of Informed Consent or patient refusal
- Postsurgery mechanical ventilation or repeated surgery in follow-up month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital Universitario Marqués de Valdecilla de Santander
Santander, Cantabria, 39008, Spain
Hospital Clinic
Barcelona, 08036, Spain
Hospital Universitario Ramón y Cajal de Madrid
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario de Salamanca (CAUSA)
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Limitations and Caveats
Only the population in which a very high rate of PAL is expected was enrolled. There was no stratification by lung function or type of lung resection.
Results Point of Contact
- Title
- Dr. Marcelo Jiménez
- Organization
- Hospital Universitario de Salamanca
Study Officials
- STUDY DIRECTOR
Gonzalo Varela, MD PhD FETCS
IBSAL-Instituto de Investigación Biomédica de Salamanca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2015
First Posted
July 8, 2015
Study Start
November 24, 2015
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
August 9, 2021
Results First Posted
July 27, 2021
Record last verified: 2021-08