Randomized clinical trial of a new cyanoacrylate flexible tissue adhesive (Adhflex) for repairing surgical wounds.

Unlabelled: The use of synthetic adhesives such as cyanoacrylates for closing surgical wounds remains controversial. In a multicenter, prospective and randomized clinical trial, we compared a new cyanoacrylate elastic tissue adhesive, Adhflex, with standard suturing methods for repairing surgical wounds. Sixty patients who underwent surgery for inguinal hernia were randomly chosen for Adhflex or standard silk suture. We evaluated wound closure time and parameters related to wound healing and complications using the Hollander Scale; overall surgeon, patient, and independent evaluator satisfaction with scar appearance using a visual analog scale; and scar cosmesis and cosmetic outcome using the Patient and Observer Scar Assessment Scale. The major finding of this study was that surgical wound closure time (minutes) was significantly lower (p < 0.05) when using Adhflex (1.50 ± 0.63) than when using sutures (2.23 ± 0.66), reducing surgery costs. Patient, surgeon and independent evaluator satisfaction was greater with Adhflex (p < 0.05). No differences were found in the final cosmetic outcome of surgical wounds (p > 0.05). The results of this clinical trial showed that Adhflex could be considered a promising and suitable wound closure method. Undoubtedly, lower operating room times will reduce overall surgical costs. Cosmetic outcomes in the medium term are comparable to those seen with sutures, yet there is no need for dressing changes, postoperative wound checks, or removal of stitches or clips. The comfort of the patient is an important factor when considering wound closure methods.

Registration Number: Eudra CT2012-002701-22.