Efficiency of Surgical Incision ClosurePrineoNCT01996917
Use of Prineo in Breast Reduction Surgery
A study testing Prineo in people with Efficiency of Surgical Incision Closure and Post-operative Scar, run by Columbia University at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Efficiency of Surgical Incision Closure, Post-operative Scar
- What is being tested?
- Prineo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing Wise pattern breast reductions for symptomatic macromastia.
Who cannot join
- Subjects who have an allergy to cyanoacrylate, formaldehyde, surgical tape, or any other known component of the Prineo system will be excluded.
- Subjects who refuse to be photographed or refuse to have their scars assessed by a blinded plastic surgeon will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10021
About this study
Official title: Use of Prineo™ for Wound Closure in Breast Reduction Surgery
This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.
Read the detailed description
Wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. Moreover, appearance of the resulting scar depends largely on surgeon technique. Use of the Prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures.
The main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. The investigators hypothesize that operative time to closure of the final skin layer using Prineo™ will be faster than operative time to closure using subcuticular suture. The investigators also hypothesize that subjective and objective scar quality of incisions closed with Prineo™ will be better than those closed with subcuticular suture.
- Being tested
- Prineo
- Keywords
- wound closure, prineo, scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrineoDevice
Also called Prineo wound closure system
After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
| Study group | Role | What they receive |
|---|---|---|
| Prineo closure | Active comparator | One breast will have skin closure with Prineo. Receives: Device: Prineo |
| Standard Suture | No intervention | One breast will be closed in the standard fashion with suture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time to Closure of Final Skin Layer
This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.
Measured: During operation only
Secondary outcomes (1)
Score on Patient Observer Scar Assessment Scale (POSAS)
The subject will complete the subjective part of the Patient Observer Scar Assessment Scale (POSAS) at each post-operative time point. Total score ranges from 6 to 60, with a higher score indicating a worse scar.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionDec 2016
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Efficiency of Surgical Incision ClosureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Christine Hsu Rohde, MD, Columbia University
- Investigators
- Christine Rohde, MD,MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996917
- Sponsor's protocol ID
- AAAM2053
- Acronym
- Prineo
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2013
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PubMed 16079683Dunst KM, Auboeck J, Zahel B, Raffier B, Huemer GM. Extensive allergic reaction to a new wound closure device (Prineo). Allergy. 2010 Jun 1;65(6):798-9. doi: 10.1111/j.1398-9995.2009.02243.x. Epub 2009 Nov 11. No abstract available.
PubMed 19909297
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Prineo™ for Wound Closure in Breast Reduction Surgery
- ClinicalTrials.gov ID
- NCT01996917
- Acronym / sponsor ID
- Prineo / AAAM2053
- Keywords
- wound closure, prineo, scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 7 May 2019
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, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.
Detailed description
Wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. Moreover, appearance of the resulting scar depends largely on surgeon technique. Use of the Prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures.
The main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. The investigators hypothesize that operative time to closure of the final skin layer using Prineo™ will be faster than operative time to closure using subcuticular suture. The investigators also hypothesize that subjective and objective scar quality of incisions closed with Prineo™ will be better than those closed with subcuticular suture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prineo closure | Active comparator | Device: PrineoOne breast will have skin closure with Prineo. |
| Standard Suture | No intervention | –One breast will be closed in the standard fashion with suture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing Wise pattern breast reductions for symptomatic macromastia.
Key exclusion criteria (2 listed)
- Subjects who have an allergy to cyanoacrylate, formaldehyde, surgical tape, or any other known component of the Prineo system will be excluded.
- Subjects who refuse to be photographed or refuse to have their scars assessed by a blinded plastic surgeon will be excluded.
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 |
|---|---|---|
| PrineoAlso: Prineo wound closure systemAfter a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures. | Device | Prineo closure |
Primary outcome
Operative Time to Closure of Final Skin Layer
Time frame: During operation only
This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.
1 secondary outcome
Score on Patient Observer Scar Assessment Scale (POSAS)
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Background: PubMed 16079683van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
- Background: PubMed 19909297Dunst KM, Auboeck J, Zahel B, Raffier B, Huemer GM. Extensive allergic reaction to a new wound closure device (Prineo). Allergy. 2010 Jun 1;65(6):798-9. doi: 10.1111/j.1398-9995.2009.02243.x. Epub 2009 Nov 11. No abstract available.
Related trials for Efficiency of Surgical Incision Closure
Not yet recruiting
Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)
Appendicitis, Surgical Wound Infection
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.
Christine Rohde, MD,MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prineo in people with Efficiency of Surgical Incision Closure and Post-operative Scar, run by Columbia University at 1 site in United States.
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 1 inclusion and 2 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2019). 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?
Operative Time to Closure of Final Skin Layer (time frame: During operation only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01996917, which also lists 3 linked publications.
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 7 May 2019.