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Late Effects of Open Wound clinical trials

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NCT ID: NCT01544556 Completed - Clinical trials for Late Effects of Open Wound

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

Start date: July 2009
Phase: N/A
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 Prineoâ„¢ 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.