Chest Wall MechanicsNCT07148648
Institutional Experience With Chest Wall Reconstruction Using Sternal Steel Wires: A Case Series Study
An observational study of Chest Wall Mechanics and Chest Wall Deformity, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Chest wall resections, often performed for tumors, infections, or trauma, result in significant defects that require reconstruction to restore structural integrity and functionality. The use of twisted stainless steel wires (No. 05) for chest wall reconstruction offers a cost-effective and practical alternative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Wall Mechanics, Chest Wall Deformity, Chest Wall Tumor
- What is being tested?
- Chest Wall Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants diagnosed with conditions requiring chest wall reconstruction and admitted to the thoracic surgery ward, emergency department, or outpatient department during the study period will be included in this study.
Who may be able to join
- Patients undergoing chest wall resection due to tumors or trauma.
Who cannot join
- Patients with contraindications to General Anesthesia.
- Patients having chest wall infection.
- Patients with pre-existing chest wall deformities or severe chronic respiratory diseases.
- Patients who undergo reoperation or develop intraoperative complications affecting the chest wall reconstruction.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute Of Medical Sciences (SIMS), Services Hospital, Lahore
Lahore, Punjab Province
About this study
Chest wall resections, often performed for tumors, infections, or trauma, result in significant defects that require reconstruction to restore structural integrity and functionality. The use of twisted stainless steel wires (No. 05) for chest wall reconstruction offers a cost-effective and practical alternative. Steel wires provide robust structural support, allow dynamic movement of the chest wall during respiration, and are associated with improved postoperative pain control.
Read the detailed description
The chest wall, a complex dynamic structure composed of both rigid and soft tissues, plays a vital role in protecting thoracic organs and maintaining the mechanics of respiration. Reconstruction following chest wall resection is critical not only to achieve defect closure but also to preserve respiratory mechanics and minimize postoperative complications. The primary goals include providing structural support, ensuring stability, and achieving soft tissue coverage while maintaining chest wall flexibility and minimizing pain. Chest wall reconstruction using sternal steel wires enable better chest wall recoil, which is crucial for maintaining normal respiratory mechanics. Additionally, studies suggest that the use of steel wires reduces the incidence of chronic pain, as they do not involve direct exposure to synthetic materials that could irritate surrounding tissues or provoke inflammatory responses. The affordability and simplicity of steel wire-based reconstruction make it particularly suitable for underserved populations in Pakistan, where healthcare resources are limited, and the majority of patients cannot afford expensive surgical materials.
- Being tested
- Chest Wall Reconstruction
- Keywords
- sternal steel wires, chest wall reconstruction, respiratory mechanics, flail segment, chest wall tumors, chest wall resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Wall ReconstructionProcedure or surgery
there are many methods described in literature for reconstruction of chest wall after chest wall resection. The investigators are focusing on chest wall reconstruction using steel wires in this study.
| Study group | Role | What they receive |
|---|---|---|
| Wires Group | all the participants who undergo chest wall reconstruction using sternal steel wires, number 05 are included in this group. Receives: Procedure: Chest Wall Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Wall Recoil
Chest wall recoil after reconstruction is defined as maintenance of normal chest wall movement during respiration without paradoxical motion.
It is assessed using spirometry (Forced Vital Capacity [FVC] and Forced Expiratory Volume in 1 second [FEV1]) compared with baseline/preoperative predicted values, radiological evaluation (postoperative chest X-rays for symmetrical expansion) and clinical observation (absence of paradoxical chest wall movement on examination).
Preserving chest wall recoil is essential for normal breathing mechanics. Reconstruction with sternal steel wires aims to restore physiological elasticity, maintain ventilatory efficiency, and reduce respiratory complications.
Measured: 30 days post-operatively
Secondary outcomes (1)
Post-Operative Pain Control
Post-operative pain control is measured using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). It is recorded at 24 hours, 72 hours, and 7 days postoperatively.
Pain is a critical determinant of recovery, respiratory function, and overall patient satisfaction. Evaluating pain scores will help determine whether sternal steel wire fixation provides a less painful and more tolerable method of chest wall reconstruction compared to alternative techniques.
Measured: 24 hours, 72 hours and 07 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 May 2023
- Primary completion30 Apr 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall MechanicsStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Sarwar, University of Health Sciences Lahore
- Investigators
- Muhammad Shoaib Nabi, Professor Of Thoracic Surgery, Principal investigator, Services Institute Of Medical Sciences (SIMS), Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148648
- Sponsor's protocol ID
- IRB/2025/1653/SIMS
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Experience With Chest Wall Reconstruction Using Sternal Steel Wires: A Case Series Study
- ClinicalTrials.gov ID
- NCT07148648
- Acronym / sponsor ID
- IRB/2025/1653/SIMS
- Keywords
- sternal steel wires, chest wall reconstruction, respiratory mechanics, flail segment, chest wall tumors, chest wall resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Aug 2025 (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.
Chest wall resections, often performed for tumors, infections, or trauma, result in significant defects that require reconstruction to restore structural integrity and functionality. The use of twisted stainless steel wires (No. 05) for chest wall reconstruction offers a cost-effective and practical alternative. Steel wires provide robust structural support, allow dynamic movement of the chest wall during respiration, and are associated with improved postoperative pain control.
Detailed description
The chest wall, a complex dynamic structure composed of both rigid and soft tissues, plays a vital role in protecting thoracic organs and maintaining the mechanics of respiration. Reconstruction following chest wall resection is critical not only to achieve defect closure but also to preserve respiratory mechanics and minimize postoperative complications. The primary goals include providing structural support, ensuring stability, and achieving soft tissue coverage while maintaining chest wall flexibility and minimizing pain. Chest wall reconstruction using sternal steel wires enable better chest wall recoil, which is crucial for maintaining normal respiratory mechanics. Additionally, studies suggest that the use of steel wires reduces the incidence of chronic pain, as they do not involve direct exposure to synthetic materials that could irritate surrounding tissues or provoke inflammatory responses. The affordability and simplicity of steel wire-based reconstruction make it particularly suitable for underserved populations in Pakistan, where healthcare resources are limited, and the majority of patients cannot afford expensive surgical materials.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wires Group | – | Procedure: Chest Wall Reconstructionall the participants who undergo chest wall reconstruction using sternal steel wires, number 05 are included in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants diagnosed with conditions requiring chest wall reconstruction and admitted to the thoracic surgery ward, emergency department, or outpatient department during the study period will be included in this study.
Key inclusion criteria (1 listed)
- Patients undergoing chest wall resection due to tumors or trauma.
Key exclusion criteria (4 listed)
- Patients with contraindications to General Anesthesia.
- Patients having chest wall infection.
- Patients with pre-existing chest wall deformities or severe chronic respiratory diseases.
- Patients who undergo reoperation or develop intraoperative complications affecting the chest wall reconstruction.
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 |
|---|---|---|
| Chest Wall Reconstructionthere are many methods described in literature for reconstruction of chest wall after chest wall resection. The investigators are focusing on chest wall reconstruction using steel wires in this study. | Procedure or surgery | Wires Group |
Primary outcome
Chest Wall Recoil
Time frame: 30 days post-operatively
Chest wall recoil after reconstruction is defined as maintenance of normal chest wall movement during respiration without paradoxical motion. It is assessed using spirometry (Forced Vital Capacity [FVC] and Forced Expiratory Volume in 1 second [FEV1]) compared with baseline/preoperative predicted values, radiological evaluation (postoperative chest X-rays for symmetrical expansion) and clinical observation (absence of paradoxical chest wall movement on examination). Preserving chest wall recoil is essential for normal breathing mechanics. Reconstruction with sternal steel wires aims to restore physiological elasticity, maintain ventilatory efficiency, and reduce respiratory complications.
1 secondary outcome
Post-Operative Pain Control
Time frame: 24 hours, 72 hours and 07 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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. This study is not recruiting at the moment.
Muhammad Shoaib Nabi, Professor Of Thoracic Surgery principal investigator
Services Institute Of Medical Sciences (SIMS), Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Wall Mechanics and Chest Wall Deformity, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chest Wall Recoil (time frame: 30 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.