The objective of this study was to determine if the utilization of an absorbable barbed suture (V-LocTM 180/90) for dermal closure could safely decrease overall OR time as compared to conventional closure by minimizing or obviating the need for multiple interrupted deep dermal sutures.
Methods/Technique:
A prospective, randomized, multi-center study evaluating an absorbable barbed suture (V-LocTM 180/90) compared to standard absorbable monofilament(MonocrylTM). The V-Loc™ Absorbable Wound Closure Devices (V-Loc; Covidien, Mansfield, MA) consist of a unidirectional barbed absorbable suture with a welded loop end. Two versions of the V-Loc device (V-Loc 180 and V-Loc 90) have been developed. Both share the same design elements, but differ in material composition. V-Loc 180 consists of a copolymer of glycolic acid and trimethylene carbonate and has a 180 day absorption profile; whereas, V-Loc 90 is composed of glycolide, diaxanone, and trimethylene carbonate and has a 90-110 day absorption profile.
Dermal closure was performed in subjects undergoing abdominoplasty, mastopexy, or reduction mammaplasty. Standard of care closure was randomized to right or left side in each patient (deep dermal MonocrylTM sutures spaced 2cm apart followed by running intradermal MonocrylTM) while the other side was closed with deep dermal MonocrylTM sutures only at sites of tension and spaced at least 5cm apart, followed by a running V-LocTM intradermal closure. Each subject served as an internal control. Time of closure and complications were assessed. Subjects were analyzed for cosmetic appearance by a blinded independent reviewer at three months on a 5-point visual analog scale.
Results/Complications:
A total of 241 patients were enrolled in the study from August 13, 2009 to January 31, 2010. Of those, 229 were randomized and treated. V-Loc 180 and V-Loc 90 were used as the study suture in 115 and 114 patients, respectively. Of patients receiving V-Loc 180, 94 completed the study. Of the 114 patients receiving V-Loc 90, 110 completed the study.
All randomized patients were included in the primary efficacy and safety analyses (115 and 114 for V-Loc 180 and V-Loc 90, respectively). One hundred and ninety patients were included in the cosmesis analysis (V-Loc 180, 88 patients; V-Loc 90, 102 patients).
Overall, the mean dermal closure time was 12.0 minutes with V-Loc compared with 19.2 minutes with the control suture, a difference of 7.2 minutes (p<0.001). This difference was primarily due to the fact that fewer deep dermal sutures were needed with V-Loc, as the difference in time for the running closure of the intradermal layer did not reach significance (8.9 minutes for V-Loc vs. 9.3 minutes for control suture; p=0.07). A similar pattern was observed when the devices were compared in just abdominal procedures, or just breast procedures.
Differences in the number of sutures used mirrored differences seen in closure times. Overall, fewer sutures were used with V-Loc than with control suture (2.0 vs 3.3, respectively; P<0.001). Although suture usage was significantly less with V-Loc than the control suture in deep dermal closure (1.4 vs 2.3, respectively; P<0.001), there was no significant difference in intradermal closure (1.1 for both groups). A similar pattern was observed when the devices were compared in only abdominal procedures, breast procedures, or whether deep dermal sutures were used.
The faster absorbing V-Loc 90 showed a complication profile equivalent to the control suture, while the V-Loc 180 had a higher incidence of minor suture extrusion.
An independent, blinded plastic surgeon evaluated photographs of the scars taken at the 12-week visit. Overall, the median total composite cosmesis score was 14.0 for both V-Loc and the control suture, and no significant difference was observed between treatment groups.
Conclusion:
The results of this trial support the use of V-Loc in abdominoplasty, mastopexy, and reduction mammaplasty with fewer deep dermal sutures. V-Loc appears to provide a secure closure and can be safely used to close the dermal layer in a running fashion with sparsely placed or no interrupted deep dermal sutures used. Furthermore, when 2 versions of this suture were compared, the version with a faster absorption profile (V-Loc 90) showed a lower minor complication rate and appeared to be more appropriate for these procedures.