Use of Platelet-Rich Plasma to Reduce Sternal Wound Complications After CABG With Median Sternotomy

NCT07352020 | Completed

• 2 other identifiers: 20-4/AS&RB-M/SZABMU/2022-F.1-1/2015/ERB/SZAMU/932
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether applying autologous platelet-rich plasma (PRP) to the sternal wound during heart surgery improves wound healing and reduces complications after surgery. The study also aims to evaluate whether PRP can reduce hospital-related outcomes and costs. The main questions this study aims to answer are: Does the use of PRP reduce superficial \& deep sternal wound infections and rate of readmissions? Does PRP improve wound healing after heart surgery? Does PRP reduce the cost of hospitalization and length of ICU stay. Does PRP reduce the requirement of red cell concentrate (RCC) and platelets to less than 4 units each Researchers will compare PRP applied to the sternal wound before closure with standard sternal wound closure alone to determine whether PRP provides additional benefit beyond standard surgical care. Participants were randomly assigned to one of two groups. Participants will: Receive standard sternal wound closure or PRP applied to the sternal wound followed by standard closure Be monitored for wound infections and healing outcomes after surgery Have hospital cost, RCC \& platelet units used, ICU stay, and readmission data recorded during the postoperative period Patients and outcome assessors were blinded to the treatment assignment. Surgeons were aware of the intervention due to the nature of the procedure. This study aims to determine whether adding PRP to standard sternal closure can improve recovery and reduce complications following cardiac surgery.

Conditions

Surgical Site Infection (SSI); Mediastinitis; Delayed Wound Healing

Keywords

Sternal wound infection; Superficial sternal wound infection; Deep sternal wound infection; Surgical site infection; Delayed wound healing; Median sternotomy; Cardiac surgery; Postoperative wound complications; Hospital length of stay; Cost analysis; Platelet rich plasma; coronary artery bypass grafting; wound healing; CABG; readmission rate

Outcome Measures

Primary Outcomes (1)

• Superficial & Deep Sternal Wound Infections, Delayed Wound Healing and readmission.

  Superficial Sternal Wound Infection (Defined as infection limited to skin and subcutaneous tissue within 30 postoperative days, not involving the sternum, requiring local wound care and antibiotic therapy or Vacuum Assisted Closure VAC therapy. Unit of Measure: Number of participants) Deep Sternal Wound Infection (Diagnosis will be made in patients developing one or more of the following within 30 postoperative days: positive culture of mediastinal tissue or fluid; clinical evidence of mediastinitis during sternal reoperation; or chest pain, sternal instability or purulent mediastinal discharge associated with a positive blood culture. Unit of Measure: Number of participants) Delayed Healing (Defined as failure of skin, subcutaneous tissue, or sternum to heal within 14 days after surgery. Unit of Measure: Number of participants) Readmission (Defined as any hospital readmission within 30 days of discharge related to the index surgery. Unit of Measure: Number of participants)

  Up to 30 days postoperatively

Secondary Outcomes (1)

• Cost of hospitalization

  From surgery to hospital discharge, up to 30 days postoperatively

Other Outcomes (1)

• Length of ICU stay and more than 4 units of red cell count (RCC) & platelets used

  Up to 30 days postoperatively

Study Arms (2)

Standard Sternal Wound Closure

ACTIVE COMPARATOR

Conventional sternal wound closure is performed without platelet-rich plasma. Participants and outcome assessors are blinded to group assignment; surgeons are aware of the intervention. Postoperative outcomes including superficial and deep sternal wound infections, delayed wound healing, cost (pre-specified secondary outcome), rate of admissions, and other observed outcomes such as length of hospital stay and more than 4 units of RCC \& platelets were assessed.

Procedure: Standard Sternal Wound Closure

PRP with Standard Sternal Wound Closure

EXPERIMENTAL

Autologous platelet-rich plasma (6 ml) is applied to the sternal wound before closure. Participants and outcome assessors are blinded to group assignment; surgeons are aware of the intervention. Postoperative outcomes including superficial and deep sternal wound infections, delayed wound healing, cost (pre-specified secondary outcome), rate of admissions, and other observed outcomes such as length of hospital stay and more than 4 units of RCC \& platelets were assessed.

Procedure: Autologous Platelet-Rich Plasma (PRP) Application

Interventions

Autologous Platelet-Rich Plasma (PRP) Application PROCEDURE

Autologous platelet-rich plasma (PRP) is prepared from the patient's own blood and applied directly to the sternal wound before standard surgical closure during cardiac surgery. The PRP contains concentrated platelets and growth factors intended to enhance wound healing and reduce infection risk. Patients in this arm receive standard sternal closure after PRP application. The procedure is performed in the operating room after sternotomy and prior to wound closure. The application is performed by the surgeon following standardized protocol to ensure consistent delivery across all participants. This intervention differs from standard closure alone and is intended to improve postoperative wound outcomes.

PRP with Standard Sternal Wound Closure

Standard Sternal Wound Closure PROCEDURE

Patients in this arm receive the standard surgical closure of the sternal wound following median sternotomy for cardiac surgery. No experimental or additional biologic products are applied. The procedure is performed according to routine surgical protocols used at the study site. This arm serves as the control group, allowing comparison of outcomes such as wound healing, infection rates, ICU stay, hospitalization cost and more than 4 units of RCC \& platelets were assessed with the experimental arm receiving platelet-rich plasma (PRP) application.

Standard Sternal Wound Closure

Eligibility Criteria

• Age: 45 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 45 to 72 years,
• undergoing median sternotomy for CABG surgery.
• Able and willing to provide informed consent.

You may not qualify if:

• Known Diabetics,
• Patients unable or ineligible to donate blood for standard blood bank procedures, which includes those with low hemoglobin, blood disorders, infections, or other medical conditions preventing safe blood collection
• Patients from whom autologous platelet-rich plasma (PRP) cannot be obtained due to low platelet counts, blood disorders, or other technical/medical reasons
• Cardiopulmonary bypass (CPB) time \> 72.5 minutes
• Bilateral internal mammary artery harvested
• Body Mass Index (BMI) \< 18.5 or \> 24.9
• Active smokers
• Chronic lung disease
• Osteoporosis
• Current steroid therapy

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Islamabad/Punjab, 44000, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Infection; Mediastinitis

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Study Officials

• Sangeen Khan Wazir, MBBS

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to group assignment. Surgeons performing the procedure and the study investigator are aware of the intervention to ensure proper delivery of PRP and adherence to the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar, Cardiac Surgery

Model Details: This interventional study uses a parallel group design. Participants undergoing median sternotomy are randomized to one of two study arms: standard sternal wound closure or autologous platelet-rich plasma (PRP) applied before standard sternal wound closure. Each participant receives only the assigned intervention. Participants and outcome assessors are blinded to group assignment, while surgeons performing the procedure are aware of the intervention. Postoperative outcomes, including primary outcomes as superficial \& deep sternal wound infections, delayed wound healing and rate of readmissions. Secondary outcome as cost (pre-specified secondary outcome) and other observed outcomes such as length of ICU stay, RCC used more than 4 units, platelets used more than 4 units are compared between groups.

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: July 7, 2022
• Primary Completion: January 7, 2023
• Study Completion: February 28, 2023
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)