Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:48 AM
Study NCT ID:
NCT07352020
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Platelet-Rich Plasma to Reduce Sternal Wound Complications After CABG With Median Sternotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D008480', 'term': 'Mediastinitis'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008477', 'term': 'Mediastinal Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-07', 'size': 134118, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-01-19T15:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of ICU stay and more than 4 units of red cell count (RCC) & platelets used', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Duration of postoperative intensive care unit (ICU) stay within 30 days following surgery. Requirement for transfusion of more than four units of red cell count (RCC) and more than four units of platelets within 30 days postoperatively.'}], 'primaryOutcomes': [{'measure': 'Superficial & Deep Sternal Wound Infections, Delayed Wound Healing and readmission.', 'timeFrame': 'Up to 30 days postoperatively', 'description': '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)\n\nDeep 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)\n\nDelayed Healing (Defined as failure of skin, subcutaneous tissue, or sternum to heal within 14 days after surgery. Unit of Measure: Number of participants)\n\nReadmission (Defined as any hospital readmission within 30 days of discharge related to the index surgery. Unit of Measure: Number of participants)'}], 'secondaryOutcomes': [{'measure': 'Cost of hospitalization', 'timeFrame': 'From surgery to hospital discharge, up to 30 days postoperatively', 'description': 'Total cost of care during hospital stay, including postoperative care, and medications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Surgical Site Infection (SSI)', 'Mediastinitis', 'Delayed Wound Healing']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions this study aims to answer are:\n\nDoes the use of PRP reduce superficial \\& deep sternal wound infections and rate of readmissions?\n\nDoes PRP improve wound healing after heart surgery?\n\nDoes PRP reduce the cost of hospitalization and length of ICU stay.\n\nDoes PRP reduce the requirement of red cell concentrate (RCC) and platelets to less than 4 units each\n\nResearchers 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.\n\nParticipants were randomly assigned to one of two groups.\n\nParticipants will:\n\nReceive standard sternal wound closure or PRP applied to the sternal wound followed by standard closure\n\nBe monitored for wound infections and healing outcomes after surgery\n\nHave hospital cost, RCC \\& platelet units used, ICU stay, and readmission data recorded during the postoperative period\n\nPatients and outcome assessors were blinded to the treatment assignment. Surgeons were aware of the intervention due to the nature of the procedure.\n\nThis study aims to determine whether adding PRP to standard sternal closure can improve recovery and reduce complications following cardiac surgery.', 'detailedDescription': "Official Title:\n\nEvaluation of Platelet Rich Plasma in Reducing Sternal Wound Complications in CABG Surgery With Median Sternotomy.\n\nStudy Background:\n\nMedian sternotomy is the standard approach for most cardiac surgeries, providing low failure rates and good long-term outcomes. However, complications such as wound infection, sternal dehiscence, and delayed healing, although uncommon, can lead to serious morbidity, longer hospital stays, and increased costs. Risk factors include obesity, diabetes, smoking, steroid use, osteoporosis, chronic lung disease, and mobilization of the internal mammary arteries. Platelet-rich plasma (PRP), which contains concentrated platelets and growth factors, has shown promise in promoting tissue healing, reducing infections, and supporting bone regeneration. PRP is used in various surgical fields but is not yet routine in cardiac surgery. Early studies suggest that applying PRP during sternotomy may reduce postoperative sternal wound complications and the need for reoperation.\n\nRationale:\n\nPostoperative complications are a significant cause of morbidity in patients undergoing cardiac surgery. Platelet-rich plasma has been proposed in clinical studies as an adjunctive therapy to reduce the incidence of complications in patients undergoing cardiac procedures via median sternotomy. The purpose of this study is to evaluate the potential benefit of platelet-rich plasma, in addition to standard care, in patients undergoing on-pump coronary artery bypass graft surgery.\n\nBrief Summary:\n\nThis study will test whether applying a patient's own platelet-rich plasma (PRP) to the breastbone area during heart surgery can help wounds heal better after coronary artery bypass surgery. Ninety-eight patients will be randomly assigned to standard closure or closure with PRP, and the study will track healing, infections, hospital stay, blood transfusions, and related costs for 30 days. The goal is to see if PRP can reduce complications and improve recovery after surgery.\n\nDetailed description:\n\nThe effect of autologous platelet-rich plasma (PRP) in this randomized controlled trial will be studied on postoperative sternal wound complications in patients undergoing on-pump coronary artery bypass graft surgery via median sternotomy. The study will enroll 98 patients aged 45 to 72 years who provide informed consent. Participants will be recruited consecutively and randomly assigned to one of two groups. All patients will undergo standard sternal closure using a midline sternotomy with a sternal saw blade, closure of the sternum with simple interrupted or figure-of-eight stainless steel wires, and layered wound closure with absorbable sutures, followed by standard dressing with Steri-Strips, gauze, and paper tape. The intervention group will additionally receive 6 mL of autologous PRP applied to the sternum and surrounding soft tissue during sternal closure. Both participants and outcome assessors will be blinded to group assignment, while surgeons performing the procedures will be aware of the intervention. The study aims to determine whether the addition of PRP to standard care reduces the frequency of sternal wound complications compared with standard sternal closure alone. All participants will provide written informed consent, and their confidentiality will be maintained. Standard care will not be altered for study purposes.\n\nStudy Design:\n\nThis is an interventional, randomized, parallel-assignment trial with double blinding (participants and outcome assessors), while the surgeons performing the procedures will be aware of the intervention. The primary purpose of the study is treatment. Participants will be randomly assigned to standard sternal closure or sternal closure with PRP.\n\nEligibility Criteria:\n\nConsenting patients from 45 to 72 years of age, undergoing on pump CABG surgery with median sternotomy.\n\nPatients will be excluded if they have a body mass index less than 18.5 or greater than 24.9, have undergone bilateral harvesting of the internal mammary artery, are receiving steroid therapy, have a known diagnosis of diabetes mellitus, are active smokers, have osteoporosis or chronic lung disease, have a cardiopulmonary bypass time exceeding 72.5 minutes, are unable to have platelet-rich plasma prepared, or are not eligible for blood bank donation.\n\nSample size\n\nThe sample size was calculated based on the primary outcome of sternal wound complications within 30 days post-surgery. Using the WHO sample size calculator with the following assumptions:\n\nLevel of significance (α) = 5% Power (1-β) = 80% Proportion of sternal wound complications in PRP group (P1) = 18% Proportion of sternal wound complications in control group (P2) = 44% The required sample size is 49 patients per group, for a total of 98 patients. This calculation ensures adequate statistical power to detect a clinically meaningful reduction in postoperative sternal wound complications between the PRP and control groups.\n\nOutcome Measures:\n\nPrimary Outcome:\n\nFrequency of sternal wound complications (delayed healing, superficial and deep infections, readmission including mediastinitis) within 30 days.\n\nSecondary Outcome:\n\nOverall cost burden (additional medications, additional antibiotics, additional laboratory tests, additional wound care, additional surgical procedure) during the 30-day postoperative period.\n\nOther Outcomes:\n\nICU stay (days), red cell transfusions \\>4 units, platelet transfusions \\>4 units.\n\nOPERATIONAL DEFINITIONS\n\nDSWI:\n\nDSWI diagnosis will be made, based on the guidelines of the CDC, in patients who developed one or more of the following: positive culture of mediastinal tissue or fluid; clinical evidence of mediastinitis during sternal reoperation; or chest pain, sternal instability, purulent discharge from the mediastinum associated with a positive blood culture. DSWI presenting in the first 30 days after operation will be included in the study.\n\nSWI:\n\nAll the infections will be considered positive that will involve skin and subcutaneous tissue within the first 30 postoperative days, not reaching the sternum, requiring local surgical intervention with regular wound care, accompanied by antibiotic therapy and/or Vacuum Assisted Closure (VAC) therapy.\n\nDelayed Healing:\n\nHealing is a complex biochemical process of tissue repair after it has been damaged. It has three stages which are inflammation, proliferation and remodelling. Delay in the specific time period or in the biochemical process is called delayed healing. Skin, subcutaneous tissue or sternum which is unable to heal within two weeks of surgery will be considered delayed wound healing.\n\nReadmission:\n\nIt is defined as any hospital readmission within 30 days of discharge related to the index surgery.\n\nICU stay:\n\nStay that refers to the duration, in days, spent in the intensive care unit, within 30 days postoperatively.\n\nBlood transfusion:\n\nIt is defined as the requirement of more than 4 units of packed red blood cells (PRBC) or platelets within 30 days postoperatively.\n\nData Collection Procedure:\n\nThe study protocol will be submitted for approval to the hospital ethics committee and Advance Research Committee, and written informed consent will be obtained from all participants. Eligible patients will be enrolled from the Cardiac Center and recruited consecutively, then randomly assigned to either the control group (standard sternal closure) or the intervention group (standard closure plus 6 mL of autologous PRP applied to the sternum and soft tissue). Standard perioperative care, including antibiotic prophylaxis, glycemic management, and general anesthesia, will be applied to all patients. Surgery will be performed via midline sternotomy, with cardiopulmonary bypass according to local guidelines, and heparinization maintained to an activated clotting time ≥480 s. Bone wax will be avoided to prevent interference with PRP. Following closure with stainless steel wires and layered sutures, standard dressings will be applied. Participants and outcome assessors will be blinded to group assignment, while surgeons will be aware of the intervention. All data will be recorded on a predesigned case report form in accordance with the study protocol.\n\nEthical Considerations:\n\nOnly patients who provide written informed consent and are willing to participate will be included.\n\nParticipants' confidentiality will be strictly maintained. Standard perioperative care will not be compromised for study purposes. All patients will be monitored for adverse events, including complications potentially related to PRP application or surgery. Any adverse events will be recorded and reported according to hospital and regulatory guidelines.\n\nThe study protocol has been submitted for approval to the Hospital Ethics Committee and the Advance Research Committee.\n\nStudy Start/Completion Dates:\n\nStudy Start Date: July 07 2022 (Actual) Primary Completion Date: January 07 2023 (Actual) Study Completion Date: February 28 2023 (Actual)\n\nLocation:\n\nDepartment of cardiac surgery, PIMS.\n\nSponsor:\n\nShaheed Zulfiqar Ali Bhutto Medical University"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 45 to 72 years,\n\nundergoing median sternotomy for CABG surgery.\n\nAble and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Known Diabetics,\n\nPatients 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\n\nPatients from whom autologous platelet-rich plasma (PRP) cannot be obtained due to low platelet counts, blood disorders, or other technical/medical reasons\n\nCardiopulmonary bypass (CPB) time \\> 72.5 minutes\n\nBilateral internal mammary artery harvested\n\nBody Mass Index (BMI) \\< 18.5 or \\> 24.9\n\nActive smokers\n\nChronic lung disease\n\nOsteoporosis\n\nCurrent steroid therapy'}, 'identificationModule': {'nctId': 'NCT07352020', 'briefTitle': 'Use of Platelet-Rich Plasma to Reduce Sternal Wound Complications After CABG With Median Sternotomy', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Zulfiqar Ali Bhutto Medical University'}, 'officialTitle': 'Evaluation of Platelet Rich Plasma in Reducing Sternal Wound Complications in CABG Surgery With Median Sternotomy', 'orgStudyIdInfo': {'id': '20-4/AS&RB-M/SZABMU/2022-'}, 'secondaryIdInfos': [{'id': 'F.1-1/2015/ERB/SZAMU/932', 'type': 'OTHER', 'domain': 'Shaheed Zulfiqar Ali Bhutto Medical University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Sternal Wound Closure', 'description': '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.', 'interventionNames': ['Procedure: Standard Sternal Wound Closure']}, {'type': 'EXPERIMENTAL', 'label': 'PRP with Standard Sternal Wound Closure', 'description': '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.', 'interventionNames': ['Procedure: Autologous Platelet-Rich Plasma (PRP) Application']}], 'interventions': [{'name': 'Autologous Platelet-Rich Plasma (PRP) Application', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['PRP with Standard Sternal Wound Closure']}, {'name': 'Standard Sternal Wound Closure', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Standard Sternal Wound Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Islamabad/Punjab', 'country': 'Pakistan', 'facility': 'Pakistan Institute of Medical Sciences', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Sangeen Khan Wazir, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Zulfiqar Ali Bhutto Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registrar, Cardiac Surgery', 'investigatorFullName': 'Sangeen khan Wazir', 'investigatorAffiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}}}}