Trial Outcomes & Findings for Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures (NCT NCT00558246)

NCT ID: NCT00558246

Last Updated: 2012-07-19

Results Overview

Equivalence was 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) did not exceed 12 percent.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 79 participants
• Primary outcome timeframe: 12-25 days
• Results posted on: 2012-07-19

Participant Flow

Subjects were recruited from the genreal popluation of those undergoing elective, bilateral breast surgery.

Participant milestones

Measure	Prineo and Suture On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Overall Study STARTED	79
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

Baseline characteristics by cohort

Measure	Prineo and Suture n=79 Participants On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. 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=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Belgium	10 participants n=5 Participants
Region of Enrollment Germany	47 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants
Region of Enrollment Sweden	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-25 days

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

Equivalence was 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) did not exceed 12 percent.

Outcome measures

Measure	Prineo n=79 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=79 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. 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.	76 Participants Interval -5.9 to 5.9	76 Participants Interval -5.9 to 5.9

SECONDARY outcome

Timeframe: Intraoperative

Population: The analysis is based upon the Intent to Treat population.

Overall time required to close final skin layer on each breast.

Outcome measures

Measure	Prineo n=79 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=79 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Time (Minutes) Required to Close the Final Skin Layer	2.56 minutes Standard Deviation 1.34	16.22 minutes Standard Deviation 6.41

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: There were 60 participants who consented to and ultimately attended all 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 breasts with good outcomes were then compared to those with poor outcomes in each group.

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

Measure	Prineo n=60 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=60 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Cosmetic Outcome	49 Incisions with good outcome	49 Incisions with good outcome

SECONDARY outcome

Timeframe: 6 months

Population: There were 60 participants who completed all follow-up visits and cosmetic evaluations.

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 breasts with good outcomes were then compared to those with poor outcomes in each group.

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

Measure	Prineo n=60 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=60 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Cosmetic Outcome	37 Incisions with good outcome	32 Incisions with good outcome

SECONDARY outcome

Timeframe: 12 months

Population: There were 59 participants who completed all follow-up visits and cosmetic evaluations.

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 breasts with good outcomes were then compared to those with poor outcomes in each group.

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

Measure	Prineo n=59 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=59 Participants On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Cosmetic Outcome	40 Incisions with good outcome	43 Incisions with good outcome

Adverse Events

Prineo

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Suture

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Procedure

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prineo n=79 participants at risk On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=79 participants at risk On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Procedure n=79 participants at risk On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Skin and subcutaneous tissue disorders Elective Brachioplasty	0.00% 0/79 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	0.00% 0/79 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	1.3% 1/79 • Number of events 1 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Infections and infestations Sepsis	0.00% 0/79 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	0.00% 0/79 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	1.3% 1/79 • Number of events 1 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.

Other adverse events

Measure	Prineo n=79 participants at risk On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Suture n=79 participants at risk On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Procedure n=79 participants at risk On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Skin and subcutaneous tissue disorders Blistering	10.1% 8/79 • Number of events 8 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	— 0/0 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	6.3% 5/79 • Number of events 5 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
General disorders Pain	21.5% 17/79 • Number of events 17 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	19.0% 15/79 • Number of events 15 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	22.8% 18/79 • Number of events 18 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Skin and subcutaneous tissue disorders Pruritus	3.8% 3/79 • Number of events 3 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	2.6% 2/78 • Number of events 2 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	6.3% 5/79 • Number of events 5 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Gastrointestinal disorders Nausea	3.8% 3/79 • Number of events 3 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	2.6% 2/78 • Number of events 2 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	15.2% 12/79 • Number of events 12 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Vascular disorders Hematoma	3.8% 3/79 • Number of events 3 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	1.3% 1/79 • Number of events 1 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	11.4% 9/79 • Number of events 9 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Psychiatric disorders Insomnia	1.3% 1/79 • Number of events 1 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	1.3% 1/79 • Number of events 1 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	5.1% 4/79 • Number of events 4 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Injury, poisoning and procedural complications Procedure Pain	7.6% 6/79 • Number of events 6 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	7.6% 6/79 • Number of events 6 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	20.3% 16/79 • Number of events 16 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Injury, poisoning and procedural complications Open Wound	5.1% 4/79 • Number of events 4 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	2.5% 2/79 • Number of events 2 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.	7.6% 6/79 • Number of events 6 • 90+/-10 days following treatment Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.

Additional Information

Phyllis Britnell

Ethicon

Phone: 1 908 218-3060

Email: pbritnel@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60