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

NCT04639089 | Unknown DMC

• 1 other identifier: MD166/2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Cardiac Surgical Procedures

Keywords

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 1. no signs of healing 2. mild healing 3. moderate healing 4. complete healing

  after the first 3 months of surgery

Study Arms (2)

We will apply 10cm plasma contain 1 million platlets on the sternal edge before sternal closure

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

We will apply 10cm saline on the sternal edge before sternal closure

PLACEBO COMPARATOR

We will apply 10cm saline on the sternal edge before sternal closure

Drug: platlet rich plasma on sternal healing post median sternotomy

Interventions

platlet rich plasma on sternal healing post median sternotomy DRUG

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

Also known as: PRP

We will apply 10cm plasma contain 1 million platlets on the sternal edge before sternal closure; We will apply 10cm saline on the sternal edge before sternal closure

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with one of which
• patients will under go open heart surgery with BMI \>30 or
• diabetic patients
• patients with history of chest wall radiotherapy exposure or
• bilateral internal mammary artery harvesting .
• age \> 70 years old

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Hamdy Singab: lead

Study Sites (1)

Hamdy Singab

Cairo, 11517, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 12403541 RESULT

• 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.

  PMID: 25722595 RESULT

• 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.

  PMID: 11063400 RESULT

• 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.

  PMID: 12406171 RESULT

• 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.

  PMID: 9638695 RESULT

• 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.

  PMID: 29984206 RESULT

• 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.

  PMID: 16921694 RESULT

Study Officials

• hamdy singab, PHD

  faculty of medicine,ain shams unversity

  STUDY DIRECTOR

Central Study Contacts

hamdy singab, PHD

CONTACT

+201001008859; hamdi_singab@hotmail.com

hamdy ahmed, PHD

CONTACT

0020226014465; drhamdy-ahmed@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 20, 2020
• Study Start: August 14, 2020
• Primary Completion: August 30, 2022
• Study Completion: December 15, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available after 3 YEARS and for 2 years.
• Access Criteria: IPD sharing access criertia including clinical researcher cardiac surgeons postgraduate investigator

Locations

EG (1)