A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02364791

Acronym

Hemopatch

Enrollment

120

Registered

2015-02-18

Start date

2015-02-28

Completion date

2024-12-31

Last updated

2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery Lung, Post-operative Thoracic Air Leak

Keywords

pulmonary resection, chest tube, segmentectomy, lobectomy

Brief summary

The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.

Interventions

DEVICEstandard techniques used to achieve air leak control

DEVICEHemopatch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥18 years * High risk of prolonged air leak due to at least one of the following reasons: * Preoperative FEV1\<80% * DLco \< 80% * LVRS (lung volume reduction surgery o pneumoplastica riduttiva) * Anticipation of intraoperative adhesions (ie, redo surgery) * Previous induction chemotherapy for locally advanced NSCLC * Chronic steroid use * Pleural mesothelioma * Candidate to one of the following major thoracic surgical intervention: * Decortication * Reintervention on the same side of the previous intervention * Segmentectomy * Lobectomy with incomplete fissures on CT scan * Written informed consent.

Exclusion criteria

* Pregnancy or breast-feeding * Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements * Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery * Known hypersensitivity to bovine proteins or brilliant blue (FD&C Blue No.1)

Design outcomes

Primary

Measure	Time frame
number of days from time of extubation to time of drainage tube removal	up to 7 days

Secondary

Measure	Time frame	Description
number of days to end of air leak	up to 7 days	air leak measure are recorded every 6 hours
worst grade toxicity per patient	up to 6 weeks	according to Common Terminology Criteria for Adverse Events version 4.0
change in quality of life	baseline, one week, one month	—
number of days from surgical intervention to patient discharge	up to 2 weeks	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026