- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658163
Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh
January 3, 2013 updated by: Medical University of Graz
Use of 2 Octyl-cyanoacrylate Together With a Self-adhering Mesh for Skin Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study
The investigators prospectively studied the results of wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing to assess the possible difference in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled at 2 weeks, 6 months and 12 months after surgery.
A panel consisting of three plastic surgeons and three plastic surgery residents assessed the wound and scar appearance during the three follow-up visits.
Study Overview
Status
Completed
Conditions
Detailed Description
Abdominoplasty is one of the most commonly performed procedures in plastic surgery.
The appearance of the scar is a major factor contributing to the aesthetic outcome of the procedure and depends largely on the technique of wound closure.
The new PrineoTM wound closure system was introduced to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh.Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study.
Total operating time after abdominoplasty between the traditional wound closure technique and the PrineoTM-type wound closure technique was compared.
Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale.
At 6- and 12-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale.
Twelve months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.There was a statistically significant shorter mean of total operating time for the new skin closure system compared with intradermal sutures.
The Hollander Cosmesis Scale indicated a significantly more favourable overall result with PrineoTM at 2 weeks after surgery.
The Vancouver Scar Scale demonstrated a better cosmetic outcome in favour of PrineoTM 6 and 12 months after surgery The Patient Scar Assessment Scale scores 12 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on our results, we conclude that PrineoTM is a safe and effective substitute for superficial skin closure, with good cosmetic results and no increase in wound complications.
The use of PrineoTM decreases operative times and costs and enhances patients' postoperative comfort.
Study Type
Observational
Enrollment (Actual)
2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- Patients who underwent an abdominoplasty without exclusion criteria
Exclusion Criteria:
- current intake of systemic steroids
- known HIV-positive or other immunocompromised status
- known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
- personal or family history of keloid or hypertrophic scar formation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daryousch Parvizi, MD, Medical University of Graz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
May 9, 2012
First Submitted That Met QC Criteria
August 3, 2012
First Posted (Estimate)
August 6, 2012
Study Record Updates
Last Update Posted (Estimate)
January 7, 2013
Last Update Submitted That Met QC Criteria
January 3, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prineo
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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