Use of PrineoTM (Dermabond Protape) Skin Adhesive for Wound Closure Following Abdominoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daryousch Parvizi, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01544556
First received: February 29, 2012
Last updated: March 5, 2012
Last verified: February 2012
  Purpose

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 investigators routinely used resorbable subcutaneous sutures and resorbable intracutaneous sutures for this closure. To overcome the potential detrimental effects of sutures in skin closure, surgical adhesives were introduced as a new technology. The new PrineoTM wound closure system was created to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh to make closure of long skin incisions even more safe and reliable. PrineoTM has the potential to offer a patient several benefits over traditional wound closure with sutures.A patient treated with Prineo™ can shower immediately following a procedure because the product forms a watertight barrier over the incision. PrineoTM can be easily removed, often with less pain than is sometimes associated with suture removal, after the natural wound healing process is complete (approximately 12 to 25 days). Other benefits are that it forms a microbial barrier and provides even distribution of tension across the length of the incision to ensure wound edge approximation throughout the wound healing process. Furthermore, it reduces subcuticular closure time as compared to subcuticular suturing.

However, these potential advantages have not been proven until now, as the methods used to assess the aesthetic outcome were not reproducible in most assessments, and none of these studies assessed patient satisfaction.1-3 Moreover, none was performed in a plastic surgical patient population. For these reasons, 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.


Condition
Late Effects of Open Wound

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of PrineoTM (Dermabond Protape) Skin Adhesive for Wound Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study

Further study details as provided by Medical University of Graz:

Enrollment: 1
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prineo
An open, prospective, controlled, randomized clinical Study
Steristrips
An open, prospective, controlled, randomized clinical Study

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. Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale. At 3- and 6-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Six months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.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 3 and 6 months after surgery The Patient Scar Assessment Scale scores 6 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on the investigators results, the investigators 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 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

Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study.

Criteria

Inclusion Criteria:

Exclusion Criteria:

peripheral vascular disease; insulin dependent diabetes mellitus; 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; or additional surgical procedures performed in the same surgical session in the same anatomical region. -

  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: NCT01544556

Locations
Austria
Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery,Medical University of Graz, Austria
GRaz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
  More Information

No publications provided

Responsible Party: Daryousch Parvizi, MD, Resident, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01544556     History of Changes
Other Study ID Numbers: Prineo 1, Prineo2
Study First Received: February 29, 2012
Last Updated: March 5, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
abdominoplasty

ClinicalTrials.gov processed this record on July 29, 2014