MacromastiaPhase 4NCT00558246
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
A Phase 4 study testing Dermabond Protape (Prineo) and Suture in people with Macromastia, run by Ethicon, Inc. at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macromastia
- What is being tested?
- Dermabond Protape (Prineo) and Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Aug 2007to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Dreifaltigkeits-Krankenhaus
Cologne
Markus Krankenhaus
Frankfurt
About this study
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
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
- Macromastia
- Being tested
- Dermabond Protape (Prineo), Suture
- Keywords
- Breast Lift, Breast Reduction, Breast Reconstruction, Plastic Surgery, Skin Closure, Wound Healing, Dermabond
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond Protape (Prineo)Device
Also called Prineo
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
SutureDevice
Also called Investigator selected the intradermal suture per standard local practice.
Topical Suturing
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. Receives: Device: Dermabond Protape (Prineo) |
| II | Active comparator | On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. Receives: Device: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-25 days
Secondary outcomes (4)
Time (Minutes) Required to Close the Final Skin Layer
Overall time required to close final skin layer on each breast.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MacromastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Colquhoun, MD, Study director, Pleiad Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558246
- Sponsor's protocol ID
- 07CS003
- Status last verified
- Jun 2012
- First submitted
- 9 Nov 2007
- Last updated
- 19 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00558246
- Acronym / sponsor ID
- 07CS003
- Conditions
- Macromastia
- Keywords
- Breast Lift, Breast Reduction, Breast Reconstruction, Plastic Surgery, Skin Closure, Wound Healing, Dermabond
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Posted 19 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: Dermabond Protape (Prineo)On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. |
| II | Active comparator | Device: SutureOn same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)];
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond Protape (Prineo)Also: Prineocyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive | Device | I |
| SutureAlso: Investigator selected the intradermal suture per standard local practice.Topical Suturing | Device | II |
Primary outcome
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.
Time frame: 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.
4 secondary outcomes
Time (Minutes) Required to Close the Final Skin Layer
Time frame: Intraoperative
Cosmetic Outcome
Time frame: 90 days post-procedure
Cosmetic Outcome
Time frame: 6 months
Cosmetic Outcome
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Colquhoun, MD study director
Pleiad Devices
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dermabond Protape (Prineo) and Suture in people with Macromastia, run by Ethicon, Inc. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Belgium, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12-25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.