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

• Sponsor: Ethicon, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00558246
• Collaborator: (none)
• Enrollment: 79
• Locations: 5
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. Breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).

Condition or Disease	Intervention/Treatment	Phase
Macromastia	Device: Dermabond Protape (Prineo); Device: Suture	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-centre Study to Show Equivalence of Prineo (DERMABOND PROTAPE) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions Associated With Breast Procedures
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Device: Dermabond Protape (Prineo); cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive; Other Names: Prineo
Active Comparator: II On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Device: Suture; Topical Suturing; Other Names: Investigator selected the intradermal suture per standard local practice.

Outcome Measures

Primary Outcome Measures

1. 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. [12-25 days]

   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.

Secondary Outcome Measures

1. Time (Minutes) Required to Close the Final Skin Layer [Intraoperative]

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

2. Cosmetic Outcome [90 days post-procedure]

   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.

3. Cosmetic Outcome [6 months]

   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.

4. Cosmetic Outcome [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be at least 18 years of age;

• Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;

• Require identical skin closure of full-thickness intersecting surgical incisions with a combined length of at least 15cm on each breast as part of elective breast procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;

• Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub until suture removal occurs (during the first 12-25 days) of the study;

• Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)], six (± 1 month) and twelve months (± 1 month)];

• Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and

• Sign the informed consent.

Exclusion Criteria:

• Have peripheral vascular disease;

• Have insulin dependent diabetes mellitus;

• Be known to have a blood clotting disorder;

• Be receiving antibiotic therapy for pre-existing condition or infection;

• Be known to be HIV-positive or otherwise immunocompromised;

• Have known personal or family history of keloid formation or hypertrophy;

• Be currently taking systemic steroids;

• Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives

• Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and

• Be participating in any current clinical trial of an investigational product or have participated in any clinical trial of an investigational product within 30 days of enrolment in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ	Gent		Belgium
2	Dreifaltigkeits-Krankenhaus	Cologne		Germany
3	Markus Krankenhaus	Frankfurt		Germany
4	Akademikliniken	Stockholm		Sweden
5	Mid Essex Hospital	Broomfield	Essex	United Kingdom

Sponsors and Collaborators

• Ethicon, Inc.

Investigators

• Study Director: Helen Colquhoun, MD, Pleiad Devices

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT00558246
• Other Study ID Numbers: 07CS003
• First Posted: Nov 14, 2007
• Last Update Posted: Jul 19, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Ethicon, Inc.: Breast Lift; Breast Reduction; Breast Reconstruction; Plastic Surgery; Skin Closure; Wound Healing; Dermabond

Study Results

Participant Flow

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

Arm/Group Title	Prineo and Suture
Arm/Group Description	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.
Period Title: Overall Study
STARTED	79
COMPLETED	79
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Prineo and Suture
Arm/Group Description	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 Participants	79
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	78 98.7%
>=65 years	1 1.3%
Sex: Female, Male (Count of Participants)
Female	79 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Belgium	10 12.7%
Germany	47 59.5%
United Kingdom	6 7.6%
Sweden	16 20.3%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	12-25 days

Outcome Measure Data

Analysis Population Description

The primary analysis is based upon intent to treat population.

Arm/Group Title	Prineo	Suture
Arm/Group Description	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Measure Participants	79	79
Number [Participants]	76 96.2%	76 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prineo, Suture
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	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%.
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Differences in proportion of successes
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -5.9 to 5.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The level of significance for statistical testing was 0.05 for this study.

2. Secondary Outcome

Title	Time (Minutes) Required to Close the Final Skin Layer
Description	Overall time required to close final skin layer on each breast.
Time Frame	Intraoperative

Outcome Measure Data

Analysis Population Description

The analysis is based upon the Intent to Treat population.

Arm/Group Title	Prineo	Suture
Arm/Group Description	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Measure Participants	79	79
Mean (Standard Deviation) [minutes]	2.56 (1.34)	16.22 (6.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prineo, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Cosmetic Outcome
Description	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.
Time Frame	90 days post-procedure

Outcome Measure Data

Analysis Population Description

There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.

Arm/Group Title	Prineo	Suture
Arm/Group Description	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Measure Participants	60	60
Number [Incisions with good outcome]	49	49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prineo, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	McNemar
	Comments

4. Secondary Outcome

Title	Cosmetic Outcome
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prineo	Suture
Arm/Group Description	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Measure Participants	60	60
Number [Incisions with good outcome]	37	32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prineo, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2266
	Comments
	Method	McNemar
	Comments

5. Secondary Outcome

Title	Cosmetic Outcome
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prineo	Suture
Arm/Group Description	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Measure Participants	59	59
Number [Incisions with good outcome]	40	43

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prineo, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5078
	Comments
	Method	McNemar
	Comments

Adverse Events

Time Frame	90+/-10 days following treatment
Adverse Event Reporting Description	Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
Arm/Group Title	Prineo		Suture		Procedure
Arm/Group Description	On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.		On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.		On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
All Cause Mortality
	Prineo		Suture		Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Prineo		Suture		Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/79 (0%)		2/79 (2.5%)
Infections and infestations
Sepsis	0/79 (0%)	0	0/79 (0%)	0	1/79 (1.3%)	1
Skin and subcutaneous tissue disorders
Elective Brachioplasty	0/79 (0%)	0	0/79 (0%)	0	1/79 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Prineo		Suture		Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/79 (39.2%)		21/79 (26.6%)		50/79 (63.3%)
Gastrointestinal disorders
Nausea	3/79 (3.8%)	3	2/78 (2.6%)	2	12/79 (15.2%)	12
General disorders
Pain	17/79 (21.5%)	17	15/79 (19%)	15	18/79 (22.8%)	18
Injury, poisoning and procedural complications
Procedure Pain	6/79 (7.6%)	6	6/79 (7.6%)	6	16/79 (20.3%)	16
Open Wound	4/79 (5.1%)	4	2/79 (2.5%)	2	6/79 (7.6%)	6
Psychiatric disorders
Insomnia	1/79 (1.3%)	1	1/79 (1.3%)	1	4/79 (5.1%)	4
Skin and subcutaneous tissue disorders
Blistering	8/79 (10.1%)	8	0/0 (NaN)	0	5/79 (6.3%)	5
Pruritus	3/79 (3.8%)	3	2/78 (2.6%)	2	5/79 (6.3%)	5
Vascular disorders
Hematoma	3/79 (3.8%)	3	1/79 (1.3%)	1	9/79 (11.4%)	9

Limitations/Caveats

Limitations of this study include the fact that the patient served as her own control. Additionally, as in many device studies, because of the obvious difference in the investigated and the control devices, blinding was limited.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.