Late Effects of Open Wound Clinical Trial
Official title:
Use of PrineoTM (Dermabond Protape) Skin Adhesive for Wound Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study
| Verified date | February 2012 |
| Source | Medical University of Graz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. - |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery,Medical University of Graz, Austria | GRaz | Styria |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Graz |
Austria,