CompletedNCT00558246Updated Jul 19, 2012Results posted

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

A Phase 4 interventional study of Dermabond Protape (Prineo) and Suture in Macromastia, sponsored by Ethicon, Inc.. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-19.

Sponsored by Ethicon, Inc. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 79
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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).

Conditions studied

Macromastia

Keywords

Breast Lift
Breast Reduction
Breast Reconstruction
Plastic Surgery
Skin Closure
Wound Healing
Dermabond

In context

Lead sponsor

Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 79 participants (actual)

Study arms

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)
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

Interventions

DeviceDermabond Protape (Prineo)
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
Also known as: Prineo
DeviceSuture
Topical Suturing
Also known as: Investigator selected the intradermal suture per standard local practice.

What researchers measure

Primary outcomes

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.
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

Secondary outcomes

Time (Minutes) Required to Close the Final Skin Layer
Overall time required to close final skin layer on each breast.
Time frame: Intraoperative
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.
Time frame: 90 days post-procedure
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.
Time frame: 6 months
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.
Time frame: 12 months

Results

Posted Jul 19, 2012

Limitations and 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.

Participant flow

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

Participant flow — Overall Study
Milestone	Prineo and Suture
Started	79
Completed	79
Not completed	0

Outcome measures

PrimaryContinuous 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.

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
Reported as:: Number · Participants

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.
Participants	Prineo	Suture
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 (-5.9 to 5.9)	76 (-5.9 to 5.9)

Statistical analysis

Prineo vs Suture · McNemar · p = 1.0000 · Differences in proportion of successes: 0 · 95% CI -5.9 to 5.9The level of significance for statistical testing was 0.05 for this study.

SecondaryTime (Minutes) Required to Close the Final Skin Layer

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

Time frame:: Intraoperative
Reported as:: Mean · minutes

Time (Minutes) Required to Close the Final Skin Layer
minutes	Prineo	Suture
Time (Minutes) Required to Close the Final Skin Layer	2.56 ± 1.34	16.22 ± 6.41

Statistical analysis

Prineo vs Suture · t-test, 2 sided · p = <0.0001

SecondaryCosmetic 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.

Time frame:: 90 days post-procedure
Reported as:: Number · Incisions with good outcome

Cosmetic Outcome
Incisions with good outcome	Prineo	Suture
Cosmetic Outcome	49	49

Statistical analysis

Prineo vs Suture · McNemar · p = 1.0000

SecondaryCosmetic Outcome

Time frame:: 6 months
Reported as:: Number · Incisions with good outcome

Cosmetic Outcome
Incisions with good outcome	Prineo	Suture
Cosmetic Outcome	37	32

Statistical analysis

Prineo vs Suture · McNemar · p = 0.2266

SecondaryCosmetic Outcome

Time frame:: 12 months
Reported as:: Number · Incisions with good outcome

Cosmetic Outcome
Incisions with good outcome	Prineo	Suture
Cosmetic Outcome	40	43

Statistical analysis

Prineo vs Suture · McNemar · p = 0.5078

Adverse events

Collected over 90+/-10 days following treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Prineo	—	0/79 (0%)	31/79 (39.2%)
Suture	—	0/79 (0%)	21/79 (26.6%)
Procedure	—	2/79 (2.5%)	50/79 (63.3%)

Most frequent serious events

Most frequent serious events
Event	Prineo	Suture	Procedure
Elective BrachioplastySkin and subcutaneous tissue disorders	0/79	0/79	1/79
SepsisInfections and infestations	0/79	0/79	1/79

Most frequent other events

Most frequent other events
Event	Prineo	Suture	Procedure
PainGeneral disorders	17/79	15/79	18/79
Procedure PainInjury, poisoning and procedural complications	6/79	6/79	16/79
NauseaGastrointestinal disorders	3/79	2/78	12/79
HematomaVascular disorders	3/79	1/79	9/79
BlisteringSkin and subcutaneous tissue disorders	8/79	—	5/79
Open WoundInjury, poisoning and procedural complications	4/79	2/79	6/79
PruritusSkin and subcutaneous tissue disorders	3/79	2/78	5/79
InsomniaPsychiatric disorders	1/79	1/79	4/79

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Prineo and Suture
<=18 years	0
Between 18 and 65 years	78
>=65 years	1

Sex: Female, Male
Sex: Female, Male(Participants)	Prineo and Suture
Female	79
Male	0

Region of Enrollment
Region of Enrollment(participants)	Prineo and Suture
Belgium	10
Germany	47
United Kingdom	6
Sweden	16

Study locations

5 sites

UZ
Gent, Belgium
Dreifaltigkeits-Krankenhaus
Cologne, Germany
Markus Krankenhaus
Frankfurt, Germany
Akademikliniken
Stockholm, Sweden
Mid Essex Hospital
Broomfield, Essex, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00558246
Lead sponsor: Ethicon, Inc.
Responsible party: Sponsor
First posted: Nov 14, 2007
Start date: Aug 2007
Primary completion: Sep 2008
Completion: Oct 2009
Results posted: Jul 19, 2012
Last update: Jul 19, 2012

Study contacts

Helen Colquhoun, MD

study director · Pleiad Devices

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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

Study summary

Conditions studied

Keywords

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria