NCT06115447

Brief Summary

Comparative study comparing polypropylene and Polyglactin in suturing of the lung

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Apr 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Apr 2024Oct 2028

First Submitted

Initial submission to the registry

October 11, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Expected
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 11, 2023

Last Update Submit

October 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • duration in days of intercostal tube air leak with each group

    Polypropylene vs Polyglactin

    2 weeks

Study Arms (2)

Polyglactin group

lung suturing with polyglactin

Procedure: lung suturing with polyglactin

Polypropylene Arm

lung suturing with Polypropylene

Procedure: ung suturing with polypropylene

Interventions

lung suturing with polyglactin

Polyglactin group

ung suturing with polypropylene

Polypropylene Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients presented to cardiothoracic surgery department and trauma department with the inclusion criteria applied

You may qualify if:

  • Patients admitted to Assiut University Hospital And will undergo surgery for lung tear repair.
  • Patients admitted to Assiut University Hospital And will undergo surgery for bullectomy or lobectomy.

You may not qualify if:

  • Patients with lung injury repaired with a stapler

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Regan T, Lawrence N. Comparison of poliglecaprone-25 and polyglactin-910 in cutaneous surgery. Dermatol Surg. 2013 Sep;39(9):1340-4. doi: 10.1111/dsu.12265. Epub 2013 Aug 13.

    PMID: 23941601BACKGROUND
  • Rendeki S, Molnar TF. Pulmonary contusion. J Thorac Dis. 2019 Feb;11(Suppl 2):S141-S151. doi: 10.21037/jtd.2018.11.53.

    PMID: 30906578BACKGROUND
  • Romby P, Carbon P, Westhof E, Ehresmann C, Ebel JP, Ehresmann B, Giege R. Importance of conserved residues for the conformation of the T-loop in tRNAs. J Biomol Struct Dyn. 1987 Dec;5(3):669-87. doi: 10.1080/07391102.1987.10506419.

    PMID: 3078237BACKGROUND

MeSH Terms

Conditions

Lung InjuryBlisterLung Neoplasms

Interventions

Polyglactin 910Polypropylenes

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and InjuriesSkin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

PolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPlastics

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 11, 2023

First Posted

November 3, 2023

Study Start

April 15, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

October 30, 2028

Last Updated

November 3, 2023

Record last verified: 2023-10