Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray
Conditions
Keywords
Fibrin, white petrolatum, wound healing
Brief summary
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.
Interventions
BIOLOGICALFibrin
Topical application of fibrinogen spray, followed by thrombin spray
OTHERWhite Petrolatum
Topical application
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. * Are male or female, ≥ 18 years of age, of any race. * Are willing to attend all required study visits, and to comply with study procedures. * Meet none of the
Exclusion criteria
(any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | 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 | The target wounds were evaluated wound status (open/closed). |
| Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | 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 | The target wounds were evaluated wound status (open/closed) |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at a single US investigation site, between February 2, 2011 and July 5, 2011.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Amended Protocol | Non-compliance | 1 |
| Original Protocol | Protocol Amendment | 15 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized Age for all 40 participants | 30.7 years STANDARD_DEVIATION 10.2 |
| Age, Customized Age for only amended protocol participants | 32.8 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black/African American | 3 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 15 participants |
| Race/Ethnicity, Customized Non Hispanic/Latino | 10 participants |
| Race/Ethnicity, Customized Other | 3 participants |
| Race/Ethnicity, Customized White/Caucasian | 18 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 40 participants |
| Sex/Gender, Customized Female amended protocol | 12 participants |
| Sex/Gender, Customized Female entire study population | 20 participants |
| Sex/Gender, Customized Male amended protocol | 13 participants |
| Sex/Gender, Customized Male entire study population | 20 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 40 | 18 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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)
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | 12 days to closure |
| Test Article | Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | 12 days to closure |
p-value: 0.4771Log Rank
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).
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | 14.4 days to wound closure | Standard Deviation 5.5 |
| Test Article | Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. | 13.3 days to wound closure | Standard Deviation 3.3 |
p-value: 0.339395% CI: [-3.08, 0.84]Prentice-Wilcoxon test