NCT00672672

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

January 13, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2010

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

May 2, 2008

Last Update Submit

August 11, 2023

Conditions

WoundsInfection

Keywords

surgical site healing treated with autologous platlet gel

Outcome Measures

Primary Outcomes (1)

  • Healing and infection of surgical sites

    The surgical sites will be assessed for degree of healing and signs and symptoms of infection on post-op days one and three and during the patients' follow up visits in the clinic.

    30 days

Study Arms (2)

Platelet Gel

EXPERIMENTAL

Participants receive platlet gel.

Biological: autologous platelet gel

Control (No platelet gel)

PLACEBO COMPARATOR

Participants do not receive platlet gel.

Biological: autologous platelet gel

Interventions

autologous platelet gelBIOLOGICAL

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

Control (No platelet gel)Platelet Gel

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and InjuriesInfections

Study Officials

  • Ali Khoynezhad, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

January 13, 2009

Primary Completion

January 6, 2010

Study Completion

January 6, 2010

Last Updated

August 15, 2023

Record last verified: 2023-08