The Effect of Platelet Rich Pasma on Strenal Healing Post Median Strenotomy in Patients Undergoing Open Heart Surgery

Platelet-rich plasma (PRP) is an autologous concentration of human platelets in a small volume of plasma.

Because it is an autogenous preparation, PRP is inherently safe and therefore free from concerns over transmissible diseases such as HIV and hepatitis.

Its power of regeneration already proved by orthopedics and dentists in their trials to regenerate cartilages .We will use it to know its ability to enhance healing of sternum in vulnerable patients to sternal dehiscence after open heart surgery .

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgical Procedures
• Intervention / Treatment: Drug: platlet rich plasma on sternal healing post median sternotomy

Detailed Description

1. INTRODUCTION Successful healing of the sternum after open heart surgery is a complicated phenomenon because of the natural body ability often fails to efficiently repaired of the sternum in patients after open cardiac surgery (Everts 2006). Recent evidence based data suggested new modalities to increase the quality and accerelate sternal healing in high risk patients after open heart surgery vulnerable for early sternal dehiscence (Liu 2002) . PRP considers as an attractive alternative option in that manner. Marx and associates demonstrated the positive influence of PRP on bone regeneration and healing since 1998 (Marx 1998 ) . Autologous PRP carries minimal risk of infectious diseases transmission, immunologic reactions, and rejection. PRP with concentrations 4 to 5 folds of the normal average platelet (1,100,000 platelets/μl ) proved to have a remarkable increase in bone mineral density and regeneration . the market for PRP grows from $45 million in 2009 to more than $120 million by 2016 (Dawood 2018 ). Multiple factors affect the PRP efficacy in sternal bone healing and regeneration process. Platelet preparation before surgical application is an area of concern with PRP. For this issue, an appropriate anticoagulant must be used to prevent the early spontaneous activation of the platelets (Kassolis 2000 ). Several anticoagulants have been employed for PRP preparation including heparin, citrate, acid-citrate-dextrose solution A or anticoagulant citrate dextrose-A ,citrate-phos phate-dextrose ,citrate-theophylline-adenosine- dipyrimadole and ethylene diamine tetra- acetic acid moreover, several manual or automated systems have been designed for preparing PRP including clinical laboratory methods and kits (Carlson 2002). PRP produced by single- or double-step centrifugation technology via platelet-pheresis (autologous selective filtration )and the cell separators,However, these methods are rarely used nowadays, due to several factors including high cost, large volume of peripheral blood should be harvested from the patients, and potentially damage to the platelet (Dhurat 2014) . Commercially available PRP kits and devices differ in ease of use, one or two step centrifugation protocols, centrifugation speed, final PRP volume, platelet count and activation, platelet and growth factor concentrations, and final RBCs' and WBCs' count.Nevertheless, the cost of the commercial kits for PRP processing is still a challenge (Trebinjac 2020) .

2. AIM/ OBJECTIVES :

   To study the Effect of platlet rich plasma on sternal healing post median sternotomy in Patients undergoing open heart surgery

3. METHODOLOGY:

   • Type of Study: prospective clinical trial propensity matched comparative study
   • Study Setting: Patients refered to our Cardiothoracic department, Faculty of medicine, Ain Shams University and ain shams specialized hospital to perform open heart surgery who fulfill our inclusion charateria.
   • Study Period: It will be performed between march 2020 and january2022

   • Study Population:

     - Inclusion Criteria: Patients with one of which

     1. patients will under go open heart surgery with BMI >30 or
     2. diabetic patients
     3. patients with history of chest wall radiotherapy exposure or
     4. bilateral internal mammary artery harvesting .
     5. age > 70 years old -Exclusion Criteria:
     1. patient with history of open heart surgery
     2. patients with preoperative HB level <11
     3. All emergency and urgency cardiothoracic surgery
   • Sampling Method: prospective clinical trials propensity matched comparative study.
   • Sample Size: 50 patients
   • Ethical Considerations: All the patients will sign an informed consent for operation and for being involved in the research and follow up process .
   • Study Tools: platlets rich plasma
   • Preparation technique : ultra centrifuge technique
   • Study Procedures:

Patient data will be collected preoperatively and intraoperatively and these risk factors will be studied Patients will be distributed to two equal groups. Demographic data : Age - gender - weight - BMI-DM-hist. of radiotherapy exposure -BIMA

Intraoperative :

We will apply 10cm plasma contain 1 million platlets on the sternal edge of only one group of them before sternal closure.

post-operative The patients will be followed till being discharged from hospital and after the first 3 months after surgery sternal stability and absence of dehiscence will be primary out come measure

Secondary end point :

Severe form of sternal deheiscence After 3months: stability of sternum will be assessed By CT chest with 3D bone reconstruction and the value of bone density as aconfirmatory test

• Statistical Analysis:using the arithmetic mean, standard deviation using hypothesis student's "t" tests for quantitative data analysis, while qualitative data (ordinal, categorical) will be analyzed using The chi-square test (x2) (Fisher's Exact Test). For all statistical comparisons, a P value of <0.05 will be considered significant and a P value of <0.01 will be considered highly significant.
• Statistical Package:Data will be statistically analyzed using statistical package of social science (SPSS)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hamdy singab, PHD; Phone Number: 11 +201001008859; Email: hamdi_singab@hotmail.com
• Study Contact Backup: Name: hamdy ahmed, PHD; Phone Number: 0020226014465; Email: drhamdy-ahmed@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Recruiting
    • Hamdy Singab
    • Contact: hamdy singab; Phone Number: 01001008859; Email: hamdi_singab@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with one of which

  1. patients will under go open heart surgery with BMI >30 or
  2. diabetic patients
  3. patients with history of chest wall radiotherapy exposure or
  4. bilateral internal mammary artery harvesting .
  5. age > 70 years old

Exclusion Criteria:

• patient with history of open heart surgery 2- patients with preoperative HB level <11 3-All emergency and urgency cardiothoracic surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: We will apply 10cm plasma contain 1 million platlets on the sternal edge before sternal closure	Drug: platlet rich plasma on sternal healing post median sternotomy; Patient data will be collected preoperatively and intraoperatively and these risk factors will be studied Patients will be distributed to two equal groups. Demographic data : Age - gender - weight - BMI-DM-hist. of radiotherapy exposure -BIMA Intraoperative : We will apply 10cm plasma contain 1 million platlets on the sternal edge of only one group of them before sternal closure. post-operative The patients will be followed till being discharged from hospital and after the first 3 months after surgery; Other Names: PRP
Placebo Comparator: We will apply 10cm saline on the sternal edge before sternal closure	Drug: platlet rich plasma on sternal healing post median sternotomy; Patient data will be collected preoperatively and intraoperatively and these risk factors will be studied Patients will be distributed to two equal groups. Demographic data : Age - gender - weight - BMI-DM-hist. of radiotherapy exposure -BIMA Intraoperative : We will apply 10cm plasma contain 1 million platlets on the sternal edge of only one group of them before sternal closure. post-operative The patients will be followed till being discharged from hospital and after the first 3 months after surgery; Other Names: PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sternal stability and absence of dehiscence	Radiographic strenal healing score information was collected from 50 patients during clinical follow-up determined by CT chest 3D axial slices analysis at five locations ( manubrium, top of aortic arch, main pulmonary artery , aortic root and aortopulmonary window) using 5 - points quantitative scale 0:minimal healing; no signs of healing; mild healing; moderate healing; complete healing	after the first 3 months of surgery

Collaborators and Investigators

• Sponsor: Dr. Hamdy Singab
• Investigators: Study Director: hamdy singab, PHD, faculty of medicine,ain shams unversity

Publications and helpful links

General Publications

• Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
• Carlson NE, Roach RB Jr. Platelet-rich plasma: clinical applications in dentistry. J Am Dent Assoc. 2002 Oct;133(10):1383-6. doi: 10.14219/jada.archive.2002.0054.
• Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol. 2000 Oct;71(10):1654-61. doi: 10.1902/jop.2000.71.10.1654.
• Liu Y, Kalen A, Risto O, Wahlstrom O. Fibroblast proliferation due to exposure to a platelet concentrate in vitro is pH dependent. Wound Repair Regen. 2002 Sep-Oct;10(5):336-40. doi: 10.1046/j.1524-475x.2002.10510.x.
• Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.
• Dawood AS, Salem HA. Current clinical applications of platelet-rich plasma in various gynecological disorders: An appraisal of theory and practice. Clin Exp Reprod Med. 2018 Jun;45(2):67-74. doi: 10.5653/cerm.2018.45.2.67. Epub 2018 Jun 29.
• Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Surgical Procedures
• Other Study ID Numbers: MD166/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: planning to make IPD available to other researchers
• IPD Sharing Time Frame: data will be available after 3 YEARS and for 2 years.
• IPD Sharing Access Criteria: IPD sharing access criertia including clinical researcher cardiac surgeons postgraduate investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No