Sternotomy Closure,Open Heart SurgeryNCT03343990
Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure
An observational study of Sternotomy Closure,Open Heart Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients Read more about this study
- Who is it for?
- Ages 17 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sternotomy Closure,Open Heart Surgery
- What is being tested?
- Interlocking multi-twisted wires in sternal closure and Eight Figure techniqe in sternal closure
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Dec 2020
- How long will I take part?
- 2 Months
- 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 17 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patient above 16 years undergoing open heart surgery with sternotomy
Who may be able to join
- Adult patient above 16 years undergoing open heart surgery with sternotomy
- Patient is willing to comply with all follow-up visits.
- Willing and able to provide written informed consent and comply with study requirements
Who cannot join
- Pediatric patients below 16 years
- Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71621
Ali Mohamed Abdelwahab, professor, 01222442156, draliabdelwahab@yahoo.com
Ahmed Mohamed Taha, 01223971404, Taha_cts@hotmail.com
About this study
Official title: Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure Post Open Heart Surgery in Egyptian Patients
Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients
Read the detailed description
Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients
Midline sternotomy, first described by Milton in 1887 [4,7,8] remains the most popular technique of cardiac exposure because of its quick and easy performance, excellent access to the heart and great vessels. Effective prevention methods for disruption and infection of median sternotomy continue to be debated. The most important factor in preventing PSWC is a stable sternal approximation, as bony union depends on adequate reduction and immobilization of the stern costal junctions. Strict adherence of preoperative aseptic technique is crucial. Careful attention to homeostasis and meticulous surgical technique remain the mainstays of prevention and must include precise sternal alignment and stable closure. While biomechanical studies appear to be valid, their general value is limited Different sternal closure techniques
- Trans-sternal/peristernal wiring
- Bilateral and longitudinal parasternal running wires (described by Robicsek)
- Double wires
- Steel band
- Figure of eight The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture .
- Interlocking multi-twisted wires One of recent way in closure of sternal gives more stabilization. At least 6 wires have to be passed. The wires should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other the wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends buried
6- Alternative techniques
Techniques utilizing lateral sternal support are first-line options in preventing SD and wound infections. The need to provide lateral reinforcement of the sternum has led to the development of several techniques, such as A-the use of lateral staples and lateral plates B-H-shaped titanium plates C- Reinforced sternal closure system D-thermo reactive clips E- Rigid plate fixation change
The purpose of this report was to analyze (I) the efficacy of most used ways in sternal closure in our center ( interlocking multi-twisted wires and Eight figure )for the prevention of Post sternal wound complication in adult egyptian patients and find the way more efficient in sternal closure.
- Conditions
- Sternotomy Closure,Open Heart Surgery
- Being tested
- Interlocking multi-twisted wires in sternal closure, Eight Figure techniqe in sternal closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interlocking multi-twisted wires in sternal closureProcedure or surgery
Also called prakash p.punjabi
One of many ways in cloure of sternal give more stabilization. At least 6 wires have to be passed. The wirs should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other The wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends of the are burried
Eight Figure techniqe in sternal closureProcedure or surgery
The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture
| Study group | Role | What they receive |
|---|---|---|
| group A | Interlocking multi-twisted wires techniqe in sternal closure Receives: Procedure: Interlocking multi-twisted wires in sternal closure; Procedure: Eight Figure techniqe in sternal closure | |
| group B | Eight Figure techniqe in sternal closure Receives: Procedure: Interlocking multi-twisted wires in sternal closure; Procedure: Eight Figure techniqe in sternal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the sternum
Duration of complete healing of the sternum :By
- Radiological (chest x-ray ant-post view and lat view in first 6 weeks post-operative
- Clinical examination in first 6 weeks post operative
Measured: 60 days
Secondary outcomes (3)
rate of wound infection
way less liable to infect wound either skin infection or wound dehiscence
Measured: 30 days
mobilization
Early mobilization after surgery till returning to normal movement including freely arm movement
Measured: 45 days
Time of procedure
time taken by each way in sternal closure
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2019 (estimated)
- Primary completion29 Mar 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sternotomy Closure,Open Heart SurgeryStudies 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
- 40 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Rabee Hamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343990
- Sponsor's protocol ID
- sternal closure
- Status last verified
- Jan 2019
- First submitted
- 8 Sep 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Information collected by this study may contribute to decrease postoperative complication as sternal dehescince , improve local wound complication \& decrease cost by decrease hospital stay \& need for antibiotics needed for wound infection and rewiring. On the other hand patients will benefit from the clinical and radiological follow up postoperatively. There are no known risks associated with participation in this study. Patients' treatment and follow up will not be altered by any means.
Publications
Karra R, McDermott L, Connelly S, Smith P, Sexton DJ, Kaye KS. Risk factors for 1-year mortality after postoperative mediastinitis. J Thorac Cardiovasc Surg. 2006 Sep;132(3):537-43. doi: 10.1016/j.jtcvs.2006.04.037.
PubMed 16935107Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
PubMed 15296898Bottio T, Rizzoli G, Vida V, Casarotto D, Gerosa G. Double crisscross sternal wiring and chest wound infections: a prospective randomized study. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1352-6. doi: 10.1016/s0022-5223(03)00945-0.
PubMed 14666006Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.
PubMed 14726062Robicsek F, Fokin A, Cook J, Bhatia D. Sternal instability after midline sternotomy. Thorac Cardiovasc Surg. 2000 Feb;48(1):1-8. doi: 10.1055/s-2000-9945.
PubMed 10757149Schimmer C, Sommer SP, Bensch M, Leyh R. Primary treatment of deep sternal wound infection after cardiac surgery: a survey of German heart surgery centers. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):708-11. doi: 10.1510/icvts.2007.164004. Epub 2007 Sep 20.
PubMed 17884847Noyez L, van Druten JA, Mulder J, Schroen AM, Skotnicki SH, Brouwer RM. Sternal wound complications after primary isolated myocardial revascularization: the importance of the post-operative variables. Eur J Cardiothorac Surg. 2001 Apr;19(4):471-6. doi: 10.1016/s1010-7940(01)00610-8.
PubMed 11306315[11] Prakash.P.Punjabi Essentials_of_Operative cardiac surgery page 62 chest closure
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure Post Open Heart Surgery in Egyptian Patients
- ClinicalTrials.gov ID
- NCT03343990
- Acronym / sponsor ID
- sternal closure
- Conditions
- Sternotomy Closure,Open Heart Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 29 Mar 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients
Detailed description
Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients
Midline sternotomy, first described by Milton in 1887 [4,7,8] remains the most popular technique of cardiac exposure because of its quick and easy performance, excellent access to the heart and great vessels. Effective prevention methods for disruption and infection of median sternotomy continue to be debated. The most important factor in preventing PSWC is a stable sternal approximation, as bony union depends on adequate reduction and immobilization of the stern costal junctions. Strict adherence of preoperative aseptic technique is crucial. Careful attention to homeostasis and meticulous surgical technique remain the mainstays of prevention and must include precise sternal alignment and stable closure. While biomechanical studies appear to be valid, their general value is limited Different sternal closure techniques
- Trans-sternal/peristernal wiring
- Bilateral and longitudinal parasternal running wires (described by Robicsek)
- Double wires
- Steel band
- Figure of eight The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture .
- Interlocking multi-twisted wires One of recent way in closure of sternal gives more stabilization. At least 6 wires have to be passed. The wires should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other the wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends buried
6- Alternative techniques
Techniques utilizing lateral sternal support are first-line options in preventing SD and wound infections. The need to provide lateral reinforcement of the sternum has led to the development of several techniques, such as A-the use of lateral staples and lateral plates B-H-shaped titanium plates C- Reinforced sternal closure system D-thermo reactive clips E- Rigid plate fixation change
The purpose of this report was to analyze (I) the efficacy of most used ways in sternal closure in our center ( interlocking multi-twisted wires and Eight figure )for the prevention of Post sternal wound complication in adult egyptian patients and find the way more efficient in sternal closure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: Interlocking multi-twisted wires in sternal closure, Procedure: Eight Figure techniqe in sternal closureInterlocking multi-twisted wires techniqe in sternal closure |
| group B | – | Procedure: Interlocking multi-twisted wires in sternal closure, Procedure: Eight Figure techniqe in sternal closureEight Figure techniqe in sternal closure |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patient above 16 years undergoing open heart surgery with sternotomy
Key inclusion criteria (3 listed)
- Adult patient above 16 years undergoing open heart surgery with sternotomy
- Patient is willing to comply with all follow-up visits.
- Willing and able to provide written informed consent and comply with study requirements
Key exclusion criteria (2 listed)
- Pediatric patients below 16 years
- Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
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 |
|---|---|---|
| Interlocking multi-twisted wires in sternal closureAlso: prakash p.punjabiOne of many ways in cloure of sternal give more stabilization. At least 6 wires have to be passed. The wirs should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other The wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends of the are burried | Procedure or surgery | group A, group B |
| Eight Figure techniqe in sternal closureThe figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture | Procedure or surgery | group A, group B |
Primary outcome
Healing of the sternum
Time frame: 60 days
Duration of complete healing of the sternum :By 1. Radiological (chest x-ray ant-post view and lat view in first 6 weeks post-operative 2. Clinical examination in first 6 weeks post operative
3 secondary outcomes
rate of wound infection
Time frame: 30 days
mobilization
Time frame: 45 days
Time of procedure
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Results publication: PubMed 16935107Karra R, McDermott L, Connelly S, Smith P, Sexton DJ, Kaye KS. Risk factors for 1-year mortality after postoperative mediastinitis. J Thorac Cardiovasc Surg. 2006 Sep;132(3):537-43. doi: 10.1016/j.jtcvs.2006.04.037.
- Results publication: PubMed 15296898Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
- Results publication: PubMed 14666006Bottio T, Rizzoli G, Vida V, Casarotto D, Gerosa G. Double crisscross sternal wiring and chest wound infections: a prospective randomized study. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1352-6. doi: 10.1016/s0022-5223(03)00945-0.
- Results publication: PubMed 14726062Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.
- Results publication: PubMed 10757149Robicsek F, Fokin A, Cook J, Bhatia D. Sternal instability after midline sternotomy. Thorac Cardiovasc Surg. 2000 Feb;48(1):1-8. doi: 10.1055/s-2000-9945.
- Results publication: PubMed 17884847Schimmer C, Sommer SP, Bensch M, Leyh R. Primary treatment of deep sternal wound infection after cardiac surgery: a survey of German heart surgery centers. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):708-11. doi: 10.1510/icvts.2007.164004. Epub 2007 Sep 20.
- Results publication: PubMed 11306315Noyez L, van Druten JA, Mulder J, Schroen AM, Skotnicki SH, Brouwer RM. Sternal wound complications after primary isolated myocardial revascularization: the importance of the post-operative variables. Eur J Cardiothorac Surg. 2001 Apr;19(4):471-6. doi: 10.1016/s1010-7940(01)00610-8.
- Results publication[11] Prakash.P.Punjabi Essentials_of_Operative cardiac surgery page 62 chest closure
- Individual participant dataSharing planned: Undecided. Information collected by this study may contribute to decrease postoperative complication as sternal dehescince , improve local wound complication \& decrease cost by decrease hospital stay \& need for antibiotics needed for wound infection and rewiring. On the other hand patients will benefit from the clinical and radiological follow up postoperatively. There are no known risks associated with participation in this study. Patients' treatment and follow up will not be altered by any means.
Related trials for Sternotomy Closure,Open Heart Surgery
Not yet recruiting
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Sternotomy Closure,Open Heart Surgery
Active, not recruitingObservational study
Sternal Closure in High-BMI Patients: Cable vs Wire
Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2)
Not yet recruitingPhase 3
Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact
Sternotomy Closure,Open Heart Surgery
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.
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 Sternotomy Closure,Open Heart Surgery, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jan 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of the sternum (time frame: 60 days). 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 NCT03343990, which also lists 8 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 14 Jan 2019.