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The PI moved to another Institution
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The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural form of vitamin E, in preventing or reducing scar formation in human skin wounds as well as the basal levels of TCT in normal human skin and adipose tissue.
Scar formation is the physiological and inevitable end point of mammalian wound healing and there is substantial evidence that inflammation is an essential prerequisite for scarring. Although scar tissue restores the normal skin barrier, the new tissue is inferior in structural, aesthetic, and functional respects. The mammalian wound healing response may have originated during the time of high susceptibility to infection. Therefore, we may have developed speed optimized wound healing where a multiple redundant compensating rapid inflammatory response allows the wound to heal quickly without infection. The scar is then the price mammals have to pay for evolutionary survival after being wounded.
Tocotrienol may be an effective tool to prevent or reduce normal, hypertrophic, or keloid scarring by mediating the inflammatory response. Tocotrienol is a safe and convenient treatment that could be used by mouth or topically. There has never been a study on the effectiveness of tocotrienol in preventing or reducing scar formation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I Single Site Randomization | Placebo Comparator | Patients with 1 surgical scar will be given both oral placebo and topical cream placebo |
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| Group II Single Site Randomization | Active Comparator | Single surgical site will be given oral placebo and topical TCT |
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| Group III Single Site Randomization | Active Comparator | Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream |
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| Group IV Single Site Randomization | Active Comparator | Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT). |
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| Group I: Bilateral Site Randomization | Placebo Comparator | Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Vitamin E Tocotrienol supplement (TCT) | Dietary Supplement | Oral Vitamin E Tocotrienol Supplement (TCT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1.To determine the efficacy of TCT in improving the appearance of post-surgical scars following oral supplementation 2.To determine the efficacy of TCT in improving the appearance of post-surgical scars following topical application | 4 weeks prior to surgery and 12 weeks post surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandan K Sen, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSU Plastic Surgery - Knightsbridge | Columbus | Ohio | 43214 | United States | ||
| The Ohio State University |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013918 | Thrombin Time |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Group II: Bilateral Site Randomization | Active Comparator | Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites. |
|
| Group III: Bilateral Site Randomization | Active Comparator | Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site. |
|
| Group IV: Bilateral Site Randomization | Active Comparator | Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT) on one surgical site. |
|
| Normal Skin and Adipost Tissue Group | No Intervention | Normal human skin and adipose tissue will be collected |
|
| Natural Vitamin E Tocotrienol Cream (TCT) | Device | Natural Vitamin E Tocotrienol(TCT)Topical Cream |
|
|
| Placebo | Other | Oral Placebo |
|
| Placebo Cream | Other | Topical Placebo Cream |
|
| Columbus |
| Ohio |
| 43221 |
| United States |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |