Sternal Wound RepairPhase 1/2NCT03183973
Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery
A Phase 1/2 study testing PRF in people with Sternal Wound Repair, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.
Trial summary
Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches have been proposed for treatment of chronic sternal wounds in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sternal Wound Repair
- What is being tested?
- PRF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- 5 Mar 2020to 25 Dec 2020
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by segment elevation (ST) changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
- The patient is scheduled to undergo coronary artery bypass surgery.
- The patient does not possess any contraindication for cardiovascular magnetic resonance (CMR).
- The patient is capable of giving informed consent.
- The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Who cannot join
- The patient is over the age of 65 years.
- The patient has previous myocardial infarction (MI) (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other left ventricular (LV) territory.
- The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
- The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
- The patient has undergone previous cardiac surgery.
- The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
- The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
- The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
SCARM
Tabriz, East Azarbyjan, 0413
Sepideh jalilzade, MSc, 04133349525
Sepideh Jalilzadeh, Msc
About this study
Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches have been proposed for treatment of chronic sternal wounds in these patients. however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia, atherosclerosis and malnutrition have main role against wound repairing. In this study investigators aimed to treatment of patients with open heart surgery and need to strict monitoring of sternal wound repair by Platelet Rich Fibrin.
- Conditions
- Sternal Wound Repair
- Being tested
- PRF, placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFBiological
patients who will receive PRF suspension
placebo groupBiological
patients who will receive Placebo
| Study group | Role | What they receive |
|---|---|---|
| PRF group | Experimental | patients who will receive Platelet Rich Fibrin (PFR) suspension Receives: Biological: PRF |
| placebo group | Experimental | Not described Receives: Biological: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar formation
Appearance of operative scar diagnose by cardiothoracic surgeon
Measured: post operative- until release from hospitalization up to 1 month
Wound Infection
wound infection incidence diagnose by cardiothoracic surgeon
Measured: post operative- until release from hospitalization up to 1 month
Bruising
Average Bruise Change diagnose by cardiothoracic surgeon
Measured: post operative- until release from hospitalization up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start5 Mar 2020
- Primary completion15 Oct 2020 (estimated)
- Study completion25 Dec 2020 (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 Sternal Wound RepairStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCARM Institute, Tabriz, Iran
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mohammad Nouri, Ph.D, Study chair, Head of SCARM InstituteAhmad Reza Jodati, CTS, Study director, SCARM institutePeyman Keyhanvar, MD, Ph.D, Principal investigator, Deputy for translational medicine of SCARM institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183973
- Sponsor's protocol ID
- SCARM-Sternum repair
- Status last verified
- Jun 2020
- First submitted
- 31 May 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tashnizi MA, Alamdari DH, Khayami ME, Rahimi HR, Moeinipour A, Amouzeshi A, Seifalian AM. Treatment of non-healing sternum wound after open-heart surgery with allogenic platelet-rich plasma and fibrin glue-preliminary outcomes. Indian J Plast Surg. 2013 Sep;46(3):538-42. doi: 10.4103/0970-0358.122011.
PubMed 24459346Serraino GF, Dominijanni A, Jiritano F, Rossi M, Cuda A, Caroleo S, Brescia A, Renzulli A. Platelet-rich plasma inside the sternotomy wound reduces the incidence of sternal wound infections. Int Wound J. 2015 Jun;12(3):260-4. doi: 10.1111/iwj.12087. Epub 2013 May 21.
PubMed 23692143Cotogni P, Barbero C, Rinaldi M. Deep sternal wound infection after cardiac surgery: Evidences and controversies. World J Crit Care Med. 2015 Nov 4;4(4):265-73. doi: 10.5492/wjccm.v4.i4.265. eCollection 2015 Nov 4.
PubMed 26557476
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery
- ClinicalTrials.gov ID
- NCT03183973
- Acronym / sponsor ID
- SCARM-Sternum repair
- Conditions
- Sternal Wound Repair
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- SCARM Institute, Tabriz, IranOther government
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 25 Dec 2020 (estimated)
- First posted
- 12 Jun 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.
Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches have been proposed for treatment of chronic sternal wounds in these patients. however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia, atherosclerosis and malnutrition have main role against wound repairing. In this study investigators aimed to treatment of patients with open heart surgery and need to strict monitoring of sternal wound repair by Platelet Rich Fibrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF group | Experimental | Biological: PRFpatients who will receive Platelet Rich Fibrin (PFR) suspension |
| placebo group | Experimental | Biological: placebo group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by segment elevation (ST) changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
- The patient is scheduled to undergo coronary artery bypass surgery.
- The patient does not possess any contraindication for cardiovascular magnetic resonance (CMR).
- The patient is capable of giving informed consent.
- The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Key exclusion criteria (8 listed)
- The patient is over the age of 65 years.
- The patient has previous myocardial infarction (MI) (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other left ventricular (LV) territory.
- The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
- The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
- The patient has undergone previous cardiac surgery.
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 |
|---|---|---|
| PRFpatients who will receive PRF suspension | Biological | PRF group |
| placebo grouppatients who will receive Placebo | Biological | placebo group |
Primary outcome
Scar formation
Time frame: post operative- until release from hospitalization up to 1 month
Appearance of operative scar diagnose by cardiothoracic surgeon
Wound Infection
Time frame: post operative- until release from hospitalization up to 1 month
wound infection incidence diagnose by cardiothoracic surgeon
Bruising
Time frame: post operative- until release from hospitalization up to 1 month
Average Bruise Change diagnose by cardiothoracic surgeon
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Results publication: PubMed 24459346Tashnizi MA, Alamdari DH, Khayami ME, Rahimi HR, Moeinipour A, Amouzeshi A, Seifalian AM. Treatment of non-healing sternum wound after open-heart surgery with allogenic platelet-rich plasma and fibrin glue-preliminary outcomes. Indian J Plast Surg. 2013 Sep;46(3):538-42. doi: 10.4103/0970-0358.122011.
- Results publication: PubMed 23692143Serraino GF, Dominijanni A, Jiritano F, Rossi M, Cuda A, Caroleo S, Brescia A, Renzulli A. Platelet-rich plasma inside the sternotomy wound reduces the incidence of sternal wound infections. Int Wound J. 2015 Jun;12(3):260-4. doi: 10.1111/iwj.12087. Epub 2013 May 21.
- Results publication: PubMed 26557476Cotogni P, Barbero C, Rinaldi M. Deep sternal wound infection after cardiac surgery: Evidences and controversies. World J Crit Care Med. 2015 Nov 4;4(4):265-73. doi: 10.5492/wjccm.v4.i4.265. eCollection 2015 Nov 4.
- Individual participant dataSharing planned: No
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.
Mohammad Nouri, Ph.D study chair
Head of SCARM Institute
Ahmad Reza Jodati, CTS study director
SCARM institute
Peyman Keyhanvar, MD, Ph.D principal investigator
Deputy for translational medicine of SCARM institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRF in people with Sternal Wound Repair, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.
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 5 inclusion and 8 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 27 Oct 2020. 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 Iran. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ahmad Reza Jodati, CTS (0413 33349525, Jodatia@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar formation (time frame: post operative- until release from hospitalization up to 1 month). The study lists 3 primary outcomes in all. 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 NCT03183973, 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 27 Oct 2020.