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

Phase 2

Active, not recruiting

• Conditions: Thoracic Surgery Lung; Post-operative Thoracic Air Leak
• Interventions: Device: standard techniques used to achieve air leak control; Device: Hemopatch

• Registration Number: NCT02364791
• Lead Sponsor: National Cancer Institute, Naples

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard treatment plus hemopatch	standard techniques used to achieve air leak control	the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures
standard treatment	standard techniques used to achieve air leak control	standard techniques to achieve air leak control after complex thoracic surgical procedures
standard treatment plus hemopatch	Hemopatch	the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures

Primary Outcome Measures

Name	Time	Method
number of days from time of extubation to time of drainage tube removal	up to 7 days

Secondary Outcome Measures

Name	Time	Method
change in quality of life	baseline, one week, one month
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
number of days from surgical intervention to patient discharge	up to 2 weeks

Trial Locations

Locations (1)

Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS; 🇮🇹 Napoli, Italy