摘要
Background: 2-octyl cyanoacrylate (2OCA) high viscosity tissue adhesive (Medline Industries, Inc., Mundelein, IL) is a liquid topical skin adhesive. 2OCA offers the same design features and clinical utility in terms of flexibility, strength, and low complication rate as the commercially available 2OCA tissue adhesives. Additionally, 2OCA features high viscosity allowing for better control during the application process, polymerization without the use of an external activator, and a distinctive violet color for ease of application visualization. Objective: The aim of this prospective case series is to descriptively report clinical data with the application of 2OCA as a topical incision closure system in female pelvic surgery. The primary outcomes included: incisional pain, incisional dehiscence, and post-operative bleeding. The secondary outcome included drying times of the adhesive with regard to incision length. Methods: A prospective open-label observational case series study was conducted to evaluate the use of 2OCA in surgical wound closure of the topical skin in adult patients undergoing gynecologic surgical procedures. A total of 50 adult women undergoing gynecologic surgery were enrolled. 2OCA was applied only by surgeons who had undergone product training to the incisions in a standardized, protocol-defined fashion. Drying times for the adhesive and photography were recorded intraoperatively. Post treatment follow-up was conducted with queries of pain level, incisional dehiscence, and incisional bleeding immediately post-operatively, 48 hours, 5 - 10 days and 14 days post-treatment. Adverse events were documented. Results: 2OCA was applied to a total of 154 incisions from the 50 patients enrolled to the study. The procedures included: 16 laparoscopic total hysterectomies, 4 diagnostic laparoscopies, 2 laparoscopic myomectomies, 2 laparoscopic bilateral or unilateral salpingo-oophorectomies, 5 total robotic-assisted laparoscopic surgeries (2 total hysterectomies, 1 supracervical hysterectomy, 1 sacrocolpopexy, and one excision of endometriosis), 7 sacral neuromodulation procedures, and 18 midurethral slings. The overall rate of incisional dehiscence was 3% (4/154). The rate of reported incisional bleeding was 3% (4/154). There was 1 incisional infection. The pain reports based on a 10-point scale had a mean of 4.96 immediately post-operatively, which decreased to a mean score < 1 (0.2) by post-op day (POD) 14. The mean drying times for the various lengths of incisions included the following: 1.28 minutes for incisions ≤ 5 mm, 1.53 minutes for 6 - 8 mm, 1.66 minutes for 10 mm - 20 mm, and 1.57 minutes for the 40 - 50 mm incisions. In 23% (36/154) of incisions 2OCA was the sole method of skin closure. Conclusion: This study demonstrates that 2OCA is safe to use in gynecologic surgical incisions with low rates of post-operative incisional bleeding and incisional dehiscence. Post-operative reports of pain maintained expected levels for recovery. 2OCA is a practical alternative or augmentation to traditional suture closure of skin incisions at the time of gynecologic surgery.
Background: 2-octyl cyanoacrylate (2OCA) high viscosity tissue adhesive (Medline Industries, Inc., Mundelein, IL) is a liquid topical skin adhesive. 2OCA offers the same design features and clinical utility in terms of flexibility, strength, and low complication rate as the commercially available 2OCA tissue adhesives. Additionally, 2OCA features high viscosity allowing for better control during the application process, polymerization without the use of an external activator, and a distinctive violet color for ease of application visualization. Objective: The aim of this prospective case series is to descriptively report clinical data with the application of 2OCA as a topical incision closure system in female pelvic surgery. The primary outcomes included: incisional pain, incisional dehiscence, and post-operative bleeding. The secondary outcome included drying times of the adhesive with regard to incision length. Methods: A prospective open-label observational case series study was conducted to evaluate the use of 2OCA in surgical wound closure of the topical skin in adult patients undergoing gynecologic surgical procedures. A total of 50 adult women undergoing gynecologic surgery were enrolled. 2OCA was applied only by surgeons who had undergone product training to the incisions in a standardized, protocol-defined fashion. Drying times for the adhesive and photography were recorded intraoperatively. Post treatment follow-up was conducted with queries of pain level, incisional dehiscence, and incisional bleeding immediately post-operatively, 48 hours, 5 - 10 days and 14 days post-treatment. Adverse events were documented. Results: 2OCA was applied to a total of 154 incisions from the 50 patients enrolled to the study. The procedures included: 16 laparoscopic total hysterectomies, 4 diagnostic laparoscopies, 2 laparoscopic myomectomies, 2 laparoscopic bilateral or unilateral salpingo-oophorectomies, 5 total robotic-assisted laparoscopic surgeries (2 total hysterectomies, 1 supracervical hysterectomy, 1 sacrocolpopexy, and one excision of endometriosis), 7 sacral neuromodulation procedures, and 18 midurethral slings. The overall rate of incisional dehiscence was 3% (4/154). The rate of reported incisional bleeding was 3% (4/154). There was 1 incisional infection. The pain reports based on a 10-point scale had a mean of 4.96 immediately post-operatively, which decreased to a mean score < 1 (0.2) by post-op day (POD) 14. The mean drying times for the various lengths of incisions included the following: 1.28 minutes for incisions ≤ 5 mm, 1.53 minutes for 6 - 8 mm, 1.66 minutes for 10 mm - 20 mm, and 1.57 minutes for the 40 - 50 mm incisions. In 23% (36/154) of incisions 2OCA was the sole method of skin closure. Conclusion: This study demonstrates that 2OCA is safe to use in gynecologic surgical incisions with low rates of post-operative incisional bleeding and incisional dehiscence. Post-operative reports of pain maintained expected levels for recovery. 2OCA is a practical alternative or augmentation to traditional suture closure of skin incisions at the time of gynecologic surgery.