Lung InjuryNCT06115447
Polypropylene vs Polyglactin in Suturing of the Lung
An observational study of Lung Injury and Bleb Lung, run by Assiut University.
Trial summary
Comparative study comparing polypropylene and Polyglactin in suturing of the lung Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Injury, Bleb Lung, Lung Cancer
- What is being tested?
- lung suturing with polyglactin and ung suturing with polypropylene
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 30 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presented to cardiothoracic surgery department and trauma department with the inclusion criteria applied
Who may be able to join
- 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.
Who cannot join
- Patients with lung injury repaired with a stapler
About this study
Comparative study comparing polypropylene and Polyglactin in suturing of the lung
Read the detailed description
Lung tear or, pulmonary laceration is an injury in lung parenchyma, said injury can be caused by several reasons:
Blunt chest trauma Penetrating trauma such as stab wounds or firearm wounds Iatrogenic, such as faulty intercostal tube insertion
- Conditions
- Lung Injury, Bleb Lung, Lung Cancer
- Being tested
- lung suturing with polyglactin, ung suturing with polypropylene
- Medical subject headings
- Lung Injury, Blister, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung suturing with polyglactinProcedure or surgery
lung suturing with polyglactin
ung suturing with polypropyleneProcedure or surgery
ung suturing with polypropylene
| Study group | Role | What they receive |
|---|---|---|
| Polyglactin group | lung suturing with polyglactin Receives: Procedure: lung suturing with polyglactin | |
| Polypropylene Arm | lung suturing with Polypropylene Receives: Procedure: ung suturing with polypropylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration in days of intercostal tube air leak with each group
Polypropylene vs Polyglactin
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start15 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Younus, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115447
- Sponsor's protocol ID
- polyglactin lung suturing
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23941601Rendeki S, Molnar TF. Pulmonary contusion. J Thorac Dis. 2019 Feb;11(Suppl 2):S141-S151. doi: 10.21037/jtd.2018.11.53.
PubMed 30906578Romby 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.
PubMed 3078237
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypropylene vs Polyglactin in Suturing of the Lung
- ClinicalTrials.gov ID
- NCT06115447
- Acronym / sponsor ID
- polyglactin lung suturing
- Conditions
- Lung Injury, Bleb Lung, Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative study comparing polypropylene and Polyglactin in suturing of the lung
Detailed description
Lung tear or, pulmonary laceration is an injury in lung parenchyma, said injury can be caused by several reasons:
Blunt chest trauma Penetrating trauma such as stab wounds or firearm wounds Iatrogenic, such as faulty intercostal tube insertion
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyglactin group | – | Procedure: lung suturing with polyglactinlung suturing with polyglactin |
| Polypropylene Arm | – | Procedure: ung suturing with polypropylenelung suturing with Polypropylene |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presented to cardiothoracic surgery department and trauma department with the inclusion criteria applied
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with lung injury repaired with a stapler
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung suturing with polyglactinlung suturing with polyglactin | Procedure or surgery | Polyglactin group |
| ung suturing with polypropyleneung suturing with polypropylene | Procedure or surgery | Polypropylene Arm |
Primary outcome
duration in days of intercostal tube air leak with each group
Time frame: 2 weeks
Polypropylene vs Polyglactin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Background: PubMed 23941601Regan 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.
- Background: PubMed 30906578Rendeki S, Molnar TF. Pulmonary contusion. J Thorac Dis. 2019 Feb;11(Suppl 2):S141-S151. doi: 10.21037/jtd.2018.11.53.
- Background: PubMed 3078237Romby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Injury and Bleb Lung, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration in days of intercostal tube air leak with each group (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115447, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.