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The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | White Petrolatum |
|
| Test article | Other | Vehicle (fibrinogen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin | Biological | Topical application of fibrinogen spray, followed by thrombin spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | The target wounds were evaluated wound status (open/closed). | All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22 |
| Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | The target wounds were evaluated wound status (open/closed) | All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Dermatology, University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26151791 | Derived | Vivas A, Fox JD, Baquerizo Nole KL, Maderal AD, Badiavas E, Cargill DI, Slade HB, Feldman SR, Kirsner RS. Cryo-Induced Thermal Wounds: A Human Acute Wound Model. J Drugs Dermatol. 2015 Jul;14(7):734-8. |
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Subjects who met all inclusion/exclusion criteria received paired superficial thermal injuries, one on the ventral aspect of each forearm, using liquid nitrogen. The test article applied to each arm was determined by randomization code. Wound status (closed/open) was assessed by a blinded assessor.
Subjects were enrolled at a single US investigation site, between February 2, 2011 and July 5, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Original Protocol |
|
| ||||||||||||||||||
| Amended Protocol |
|
There were 40 participants in the entire study. Only 25 participants in the amended protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | The target wounds were evaluated wound status (open/closed). | ITT Populations: Subjects who participated in version 2 of the protocol. Inter-group comparison was done using a paired Prentice-Wilcoxon method, which is applicable to censored data. | Posted | Mean | Standard Deviation | days to wound closure | All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22 |
|
Safety reporting occurred over the three weeks of the treatment period.
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
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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 | Control | White Petrolatum White Petrolatum: Topical application White petrolatum was applied daily to the appropriate wound. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders & administrative site conditions | General disorders | MedDRA v 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime E Dickerson, PhD | Smith & Nephew | 1-817-302-3914 | Jaime.Dickerson@smith-nephew.com |
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| ID | Term |
|---|---|
| D005337 | Fibrin |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006838 | Hydrocarbons |
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| White Petrolatum |
| Other |
Topical application |
|
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | For amended protocol participants | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Test Article |
802-247 Vehicle (fibrinogen) Fibrin: Topical application of fibrinogen spray, followed by thrombin spray HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature. |
|
|
|
| Primary | Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | The target wounds were evaluated wound status (open/closed) | ITT Populations: Subjects who participated in version 2 of the protocol. The primary efficacy endpoint was analyzed, using Kaplan-Meier survival analysis, to estimate the median time to wound closure over the 21-day treatment period. Any wound which did not heal by Day 21 was censored in the analysis. | Posted | Median | 95% Confidence Interval | days to closure | All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22 |
|
|
|
|
| 0 |
| 40 |
| 18 |
| 40 |
| EG001 | Test Article | 802-247 Vehicle (fibrinogen) Fibrin: Topical application of fibrinogen spray, followed by thrombin spray HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature. | 0 | 40 | 18 | 40 |
| Pain | General disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
|
| Injury, poisoning & procedural complications | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
|
| Musculoskeletal & connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Skin & subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |