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Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01658163
First received: May 9, 2012
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition
Surgical Wound Dehiscence
Cutis Laxa
Wound of Skin

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of 2 Octyl-cyanoacrylate Together With a Self-adhering Mesh for Skin Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Enrollment: 2
Study Start Date: June 2009
Study Completion Date: September 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658163

Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Daryousch Parvizi, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01658163     History of Changes
Other Study ID Numbers: Prineo
Study First Received: May 9, 2012
Last Updated: January 3, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
abdominoplasty,
skin closure, dressings

Additional relevant MeSH terms:
Cutis Laxa
Surgical Wound Dehiscence
Connective Tissue Diseases
Genetic Diseases, Inborn
Pathologic Processes
Postoperative Complications
Skin Diseases
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 20, 2014