Trial Outcomes & Findings for Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions (NCT NCT01716013)
NCT ID: NCT01716013
Last Updated: 2017-01-09
Results Overview
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
10 days
Results posted on
2017-01-09
Participant Flow
Participant milestones
| Measure |
BondEase
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
54
|
|
Overall Study
COMPLETED
|
105
|
54
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
Baseline characteristics by cohort
| Measure |
BondEase
n=105 Participants
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
n=54 Participants
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 23.1 • n=99 Participants
|
47.7 years
STANDARD_DEVIATION 22.3 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 22.8 • n=206 Participants
|
|
Gender
Female
|
49 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Gender
Male
|
56 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Wound type
Injury (Laceration)
|
27 participants
n=99 Participants
|
13 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Wound type
Surgical incision
|
78 participants
n=99 Participants
|
41 participants
n=107 Participants
|
119 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Per protocol population (primary analysis dataset)
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
Outcome measures
| Measure |
BondEase
n=96 Participants
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
n=51 Participants
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
|---|---|---|
|
100% Wound Apposition at 10 Days
|
77.1 percentage of participants
|
80.4 percentage of participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intent-to-treat (ITT) population
Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days. One point was scored for the absence of, and no point was scored for the presence of, any of the following six items: * Stepoff of borders (edges not on the same plane) * Contour irregularities (wrinkled skin near wound) * Margin separation (gap between sides) * Edge inversion (wound not properly everted) * Excessive distortion (swelling or edema or infection) * Poor overall appearance. The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.
Outcome measures
| Measure |
BondEase
n=105 Participants
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
n=54 Participants
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
|---|---|---|
|
Optimal Cosmetic Outcome at 28 Days (Score of 6)
|
70.5 percentage of participants
|
64.8 percentage of participants
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intent-to-treat (ITT) population
Incidence of wounds ≥50% apposed (10 ± 3 days)
Outcome measures
| Measure |
BondEase
n=105 Participants
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
n=54 Participants
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
|---|---|---|
|
≥ 50% Wound Apposition at 10 Days
|
93.3 percentage of participants
|
96.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 Days and 90 daysPopulation: Intent-to-Treat (ITT) population
Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up
Outcome measures
| Measure |
BondEase
n=105 Participants
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
n=54 Participants
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
|---|---|---|
|
Wound Dehiscence Requiring Treatment
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
BondEase
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
CWCD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BondEase
n=105 participants at risk
Topical Skin Adhesive
BondEase: topical skin adhesive
|
CWCD
n=54 participants at risk
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dehiscence with No Need for Retreatment
|
1.9%
2/105 • Number of events 2
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Mild Scar
|
1.9%
2/105 • Number of events 2
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
7/105 • Number of events 7
|
7.4%
4/54 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.95%
1/105 • Number of events 1
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Pain
|
1.9%
2/105 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall have been furnished copies of any proposed publication or presentation at least thirty (30) days in advance of the submission of such proposed publication or presentation to a journal, editor, or other third party. Sponsor reserves the right to object to the proposed presentation or publication.
- Publication restrictions are in place
Restriction type: OTHER