Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients

NCT ID: NCT00672672

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-13
• Study Completion Date: 2010-01-06

Brief Summary

This study will determine if autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease infection in coronary artery bypass grafting surgery patients.

Detailed Description

The purpose of this study is to determine if the use of autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease the incidence of infection in patients undergoing coronary artery bypass grafting surgery

Conditions

Wounds; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Platelet Gel

Participants receive platlet gel.

Group Type: EXPERIMENTAL

autologous platelet gel

Intervention Type: BIOLOGICAL

Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.

Control (No platelet gel)

Participants do not receive platlet gel.

Group Type: PLACEBO_COMPARATOR

autologous platelet gel

Intervention Type: BIOLOGICAL

Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.

Interventions

autologous platelet gel

Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study.

Exclusion Criteria

• Any patient, after inclusion, whom is later determined to have had on-going therapy that could influence wound healing such as radiation or chemotherapy, extensive steroid use, or accidental trauma such as burns, etc.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Khoynezhad, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

0065-08-FB

Identifier Type: -

Identifier Source: org_study_id