Trial Outcomes & Findings for Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions (NCT NCT00557947)

Last Updated: 2012-07-19

Results Overview

Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

83 participants

Primary outcome timeframe

12-25 days post-operation

Results posted on

2012-07-19

Participant Flow

Subjects were recruited from the general population undergoing elective surgical procedures for body contouring.

Participant milestones

Participant milestones
Measure	Dermabond Protape/Suture Dermabond Protape-Incision segments are randomized \& patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Overall Study STARTED	83
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dermabond Protape/Suture n=83 Participants Dermabond Protape-Incision segments are randomized \& patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Sex: Female, Male Female	77 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Region of Enrollment Belgium	22 participants n=93 Participants
Region of Enrollment Germany	36 participants n=93 Participants
Region of Enrollment United Kingdom	20 participants n=93 Participants
Region of Enrollment Sweden	5 participants n=93 Participants

PRIMARY outcome

Timeframe: 12-25 days post-operation

Population: The primary analysis is based upon intent to treat population.

Outcome measures

Outcome measures
Measure	Dermabond Protape n=83 Participants Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=83 Participants Suture - Incision segments are randomized \& patient is own control.
Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.	74 Participants Interval 0.0 to 10.9	78 Participants Interval 0.0 to 10.9

SECONDARY outcome

Timeframe: Intraoperative

Population: The analysis is based upon the Intent To Treat population

Time to close final skin layer for each incision segment.

Outcome measures

Outcome measures
Measure	Dermabond Protape n=83 Participants Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=83 Participants Suture - Incision segments are randomized \& patient is own control.
Time Required to Close the Final Skin Layer	1.46 minutes Standard Deviation 0.96	6.65 minutes Standard Deviation 4.02

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.

Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.

Outcome measures

Outcome measures
Measure	Dermabond Protape n=50 Participants Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=50 Participants Suture - Incision segments are randomized \& patient is own control.
Cosmetic Outcome	33 Incisions with good outcome	37 Incisions with good outcome

SECONDARY outcome

Timeframe: 6 months

Population: There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.

Outcome measures

Outcome measures
Measure	Dermabond Protape n=50 Participants Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=50 Participants Suture - Incision segments are randomized \& patient is own control.
Cosmetic Outcome	30 Incisions with good outcomes	32 Incisions with good outcomes

SECONDARY outcome

Timeframe: 12 month

Population: There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.

Outcome measures

Outcome measures
Measure	Dermabond Protape n=49 Participants Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=49 Participants Suture - Incision segments are randomized \& patient is own control.
Cosmetic Outcome	33 Incisions with good outcome	32 Incisions with good outcome

Adverse Events

Dermabond Protape

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Suture

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Procedure

Serious events: 11 serious events

Other events: 24 other events

Deaths: 0 deaths

Unrelated

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dermabond Protape n=83 participants at risk Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=83 participants at risk Suture - Incision segments are randomized \& patient is own control.	Procedure n=83 participants at risk	Unrelated n=83 participants at risk Reported events per local regulatory requirements but not related to either device or procedure.
Surgical and medical procedures Wound Dehiscence	1.2% 1/83 • Number of events 1	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Infections and infestations Infection	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	0.00% 0/83
Surgical and medical procedures Seroma	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Surgical and medical procedures Wound Necrosis	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Injury, poisoning and procedural complications Seroma	0.00% 0/83	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	0.00% 0/83
Cardiac disorders Chest Pain	0.00% 0/83	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastic Breast Cancer	0.00% 0/83	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1
Injury, poisoning and procedural complications Procedural Complication (requiring removal of skin flap) due to congestion of blood supply	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Surgical and medical procedures Fluid Overload	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Vascular disorders Hematoma	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Injury, poisoning and procedural complications Wound Dehiscence	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	0.00% 0/83
Surgical and medical procedures Hematoma	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	0.00% 0/83
Injury, poisoning and procedural complications Wound Infection	1.2% 1/83 • Number of events 1	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Cardiac disorders Arrhythmia	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1	0.00% 0/83
Infections and infestations Breast Abcess	0.00% 0/83	0.00% 0/83	0.00% 0/83	1.2% 1/83 • Number of events 1
General disorders Necrosis	0.00% 0/83	1.2% 1/83 • Number of events 1	1.2% 1/83 • Number of events 1	0.00% 0/83

Other adverse events

Other adverse events
Measure	Dermabond Protape n=83 participants at risk Dermabond Protape-Incision segments are randomized \& patient is own control	Suture n=83 participants at risk Suture - Incision segments are randomized \& patient is own control.	Procedure n=83 participants at risk	Unrelated n=83 participants at risk Reported events per local regulatory requirements but not related to either device or procedure.
General disorders Pain (General Disorders)	19.3% 16/83 • Number of events 16	19.3% 16/83 • Number of events 16	22.9% 19/83 • Number of events 19	0.00% 0/83
Gastrointestinal disorders Nausea	0.00% 0/83	0.00% 0/83	7.2% 6/83 • Number of events 83	— 0/0
Psychiatric disorders Insomnia	0.00% 0/83	0.00% 0/83	6.0% 5/83 • Number of events 5	— 0/0
Gastrointestinal disorders Constipation	0.00% 0/83	0.00% 0/83	3.6% 3/83 • Number of events 3	7.2% 6/83 • Number of events 6
Injury, poisoning and procedural complications Procedure Pain	4.8% 4/83 • Number of events 4	4.8% 4/83 • Number of events 4	6.0% 5/83 • Number of events 5	— 0/0
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/83	0.00% 0/83	4.8% 4/83 • Number of events 4	1.2% 1/83 • Number of events 1

Additional Information

John Lombard

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