Trial Outcomes & Findings for Study to Determine if Fibrin Affects the Ability of a Wound to Heal (NCT NCT01253135)
NCT ID: NCT01253135
Last Updated: 2015-12-21
Results Overview
The target wounds were evaluated wound status (open/closed).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
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
Results posted on
2015-12-21
Participant Flow
Subjects were enrolled at a single US investigation site, between February 2, 2011 and July 5, 2011.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Original Protocol
STARTED
|
15
|
|
Original Protocol
COMPLETED
|
0
|
|
Original Protocol
NOT COMPLETED
|
15
|
|
Amended Protocol
STARTED
|
25
|
|
Amended Protocol
COMPLETED
|
24
|
|
Amended Protocol
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Original Protocol
Protocol Amendment
|
15
|
|
Amended Protocol
Non-compliance
|
1
|
Baseline Characteristics
Study to Determine if Fibrin Affects the Ability of a Wound to Heal
Baseline characteristics by cohort
| Measure |
All Participants
n=40 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.
|
|---|---|
|
Age, Customized
Age for all 40 participants
|
30.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Age, Customized
Age for only amended protocol participants
|
32.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex/Gender, Customized
Male entire study population
|
20 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female entire study population
|
20 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male amended protocol
|
13 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female amended protocol
|
12 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic/Latino
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 22Population: 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.
The target wounds were evaluated wound status (open/closed).
Outcome measures
| Measure |
Control
n=25 Participants
White Petrolatum
White Petrolatum: Topical application
White petrolatum was applied daily to the appropriate wound.
|
Test Article
n=25 Participants
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.
|
|---|---|---|
|
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
|
13.3 days to wound closure
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: 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 22Population: 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.
The target wounds were evaluated wound status (open/closed)
Outcome measures
| Measure |
Control
n=25 Participants
White Petrolatum
White Petrolatum: Topical application
White petrolatum was applied daily to the appropriate wound.
|
Test Article
n=25 Participants
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.
|
|---|---|---|
|
Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.
|
12 days to closure
Interval 11.0 to 15.0
|
12 days to closure
Interval 11.0 to 15.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Test Article
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=40 participants at risk
White Petrolatum
White Petrolatum: Topical application
White petrolatum was applied daily to the appropriate wound.
|
Test Article
n=40 participants at risk
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.
|
|---|---|---|
|
General disorders
General disorders & administrative site conditions
|
7.5%
3/40 • Number of events 6 • 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.
|
2.5%
1/40 • Number of events 2 • 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.
|
|
General disorders
Pain
|
5.0%
2/40 • Number of events 3 • 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.
|
2.5%
1/40 • Number of events 2 • 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.
|
|
Infections and infestations
Infections and Infestations
|
5.0%
2/40 • Number of events 2 • 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.
|
5.0%
2/40 • Number of events 2 • 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.
|
|
Injury, poisoning and procedural complications
Injury, poisoning & procedural complications
|
5.0%
2/40 • Number of events 2 • 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.
|
5.0%
2/40 • Number of events 2 • 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.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.0%
2/40 • Number of events 2 • 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.
|
5.0%
2/40 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & connective tissue disorders
|
5.0%
2/40 • Number of events 2 • 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.
|
7.5%
3/40 • Number of events 3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • Number of events 2 • 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.
|
7.5%
3/40 • Number of events 3 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders
|
42.5%
17/40 • Number of events 29 • 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.
|
42.5%
17/40 • Number of events 29 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
25.0%
10/40 • Number of events 10 • 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.
|
22.5%
9/40 • Number of events 10 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.5%
13/40 • Number of events 18 • 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.
|
32.5%
13/40 • Number of events 18 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60