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The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.
This will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and delayed wound healing will be lower in patients receiving PRP and PPP compared to patients who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is substantial, and involves a blood draw that would not otherwise be done. Thus, it is important to know if this treatment is effective or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving PRP and PPP. | Active Comparator | Administration of PRP and PPP to surgical site. |
|
| Control | No Intervention | Group not receiving autogenous PRP and PPP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP and PPP | Biological | Autogenous PRP and PPP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Infection and Delayed Wound Healing. | Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion). | Infection: 30 days after surgery. Delayed wound healing: 60 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary M Kiebzak, Ph.D. | Center for Research & Grants | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHZ Sports Medicine Institute | Coral Gables | Florida | 33146 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Receiving PRP and PPP. | Administration of PRP and PPP to surgical site. |
| FG001 | Control | Group not receiving autogenous PRP and PPP. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients having foot and/or ankle surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Receiving PRP and PPP. | Administration of PRP and PPP to surgical site. PRP and PPP: Autogenous PRP and PPP |
| BG001 | Control | Group not receiving autogenous PRP and PPP. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Infection and Delayed Wound Healing. | Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion). | Patients have foot and/or ankle surgery. | Posted | Number | participants | Infection: 30 days after surgery. Delayed wound healing: 60 days. |
|
60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Receiving PRP and PPP. | Administration of PRP and PPP to surgical site. |
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Originally intended to enroll more patients but due to apparent lack of effect of PRP treatment, enrollment was truncated to n = 250 per study group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary M. Kiebzak, Ph.D., Co-investigator and Clinical Research Administrator | Center for Research & Grants, Baptist Health South Florida | 786-268-6224 | garyk@baptisthealth.net |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Met postoperative exclusion criteria |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes, rheumatoid arthritis, smoking = risk factors for healing | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 250 |
| 0 |
| 250 |
| EG001 | Control | Group not receiving autogenous PRP and PPP. | 0 | 250 | 0 | 250 |
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