Trial Outcomes & Findings for Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure (NCT NCT00547638)

Results Overview

Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

216 participants

Primary outcome timeframe

14 days (±2 days)

Results posted on

2013-08-06

Participant Flow

Study subjects were recruited from the general population ≥1 year of age who were treated in an Emergency Department/Urgent Care Setting.

Participant milestones

Participant milestones
Measure	Dermabond Protape (Prineo) DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD DERMABOND HVD: Comparator tissue adhesive for topical application.
Overall Study STARTED	143	73
Overall Study COMPLETED	119	59
Overall Study NOT COMPLETED	24	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator Tissue Adhesive for Topical Application	Total n=216 Participants Total of all reporting groups
Age, Categorical <=18 years	52 Participants n=5 Participants	30 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants	39 Participants n=7 Participants	128 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	25.0 years STANDARD_DEVIATION 18.4 • n=5 Participants	25.7 years STANDARD_DEVIATION 19.8 • n=7 Participants	25.2 years STANDARD_DEVIATION 18.9 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	26 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	47 Participants n=7 Participants	138 Participants n=5 Participants
Region of Enrollment United States	143 Participants n=5 Participants	73 Participants n=7 Participants	216 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days (±2 days)

Population: Intent to treat population results are presented.With respect to Measure Description it is defined as the number of participants in each group with successful wound-closure (approximation).

Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.

Outcome measures

Outcome measures
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator tissue adhesive for topical application.
The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.	123 Participants	57 Participants

SECONDARY outcome

Timeframe: 30 days (±5 days)

Population: Intent to Treat Population where good outcome for overall appearance. A p-value of 0.457 was determined following comparison by Fisher's Exact Test.

The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.

Outcome measures

Outcome measures
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator tissue adhesive for topical application.
Cosmesis	93 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through Day 30

Population: Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30.

Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed.

Outcome measures

Outcome measures
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator tissue adhesive for topical application.
The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 Number of Infections at Day 14 Per Group	4 Participants	1 Participants
The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30 Number of Infections at Day 30 Per group	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Day 14 and Day 30

Population: Intent to treat population was analyzed for subjects in each group with Total AIRE Score of 1-12 at Day 14 and Day 30. Analysis is performed on the proportion of subjects in each group with Total AIRE Scores greater than 0 versus those less or equal to 0 at each timepoint.

Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score\>0) by treatment group and compared for differences using the Fisher's Exact Test.

Outcome measures

Outcome measures
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator tissue adhesive for topical application.
The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 Participants with Total AIRE Score >0 at Day 14	54 Participants With AIRE Score >0	35 Participants With AIRE Score >0
The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30 Participants with Total AIRE Score >0 at Day 30	55 Participants With AIRE Score >0	29 Participants With AIRE Score >0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Population: Intent to treatment population was analyzed for the incidence of skin blistering at Day 14.

The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test.

Outcome measures

Outcome measures
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator tissue adhesive for topical application.
Incidence of Skin Blistering at Day 14	0 Participants With Blistering at Day 14	0 Participants With Blistering at Day 14

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 30

Population: Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed.

Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering.

Outcome measures

Outcome measures
Measure	Dermabond Protape (Prineo) n=143 Participants DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.	Dermabond HVD n=73 Participants DERMABOND HVD: Comparator tissue adhesive for topical application.
Incidence of Any Other Anticipated or Unanticipated Adverse Events	34 Participants Experiencing at least 1 AE	10 Participants Experiencing at least 1 AE

Adverse Events

Dermabond Protape (Prineo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dermabond HVD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Lombard, Clinical Research Manager

Ethicon, Inc.

Phone: 908 218 2877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60