WoundsNCT00672672
Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
A study testing autologous platelet gel in people with Wounds and Infection, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- What is being tested?
- autologous platelet gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2009to 6 Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study.
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- autologous platelet gel
- Keywords
- surgical site healing treated with autologous platlet gel
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet gelBiological
Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Gel | Experimental | Participants receive platlet gel. Receives: Biological: autologous platelet gel |
| Control (No platelet gel) | Placebo comparator | Participants do not receive platlet gel. Receives: Biological: autologous platelet gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study start13 Jan 2009
- Primary completion6 Jan 2010
- Study completion6 Jan 2010
Why it stopped: Study closed with no subjects accrued. PI decided to stop study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Khoynezhad, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672672
- Sponsor's protocol ID
- 0065-08-FB
- Status last verified
- Aug 2023
- First submitted
- 2 May 2008
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
- ClinicalTrials.gov ID
- NCT00672672
- Acronym / sponsor ID
- 0065-08-FB
- Keywords
- surgical site healing treated with autologous platlet gel
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed with no subjects accrued. PI decided to stop study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 13 Jan 2009 (actual)
- Primary completion
- 6 Jan 2010 (actual)
- Study completion
- 6 Jan 2010 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Gel | Experimental | Biological: autologous platelet gelParticipants receive platlet gel. |
| Control (No platelet gel) | Placebo comparator | Biological: autologous platelet gelParticipants do not receive platlet gel. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous platelet gelPatients will receive APG to the surgical site in the operating room. The control site will receive no treatment. | Biological | Control (No platelet gel), Platelet Gel |
Primary outcome
Healing and infection of surgical sites
Time frame: 30 days
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
Related trials for Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Khoynezhad, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing autologous platelet gel in people with Wounds and Infection, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing and infection of surgical sites (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.