Anti-adhesive effect and safety of a thermosensitive adhesion barrier (Mediclore) for thyroid surgery: a double-blinded randomized controlled trial

Abstract

Purpose: Postoperative adhesions after thyroidectomy adversely affect patients' quality of life. This study assessed the anti-adhesive effect and safety of thermosensitive sol-gel agents for patients undergoing thyroidectomy.

Methods: A double-blind parallel-group randomized clinical trial involving patients aged 20-70 years undergoing thyroidectomy for thyroid nodules was conducted. From August 2017 to April 2020, 90 patients were randomly assigned to the experimental (n = 45, thermosensitive sol-gel agent applied to the surgical site) and control (n = 45, no treatment) groups in a 1:1 ratio. All patients were assessed using a questionnaire for swallowing difficulty, wrinkle problems, and inflammation at 2 weeks, 3 months, and 6 months after thyroid surgery. For reoperated patients, the degree of adhesion was evaluated according to the adhesion-evaluation score system (range, 0-4).

Results: During the follow-up period of 6.50 ± 1.38 months, the swallowing difficulty, wrinkle problem, and inflammation were improved in both groups. However, there was no statistically significant difference between the control and experimental groups related to swallowing difficulty, wrinkle problems, and inflammation. Two patients in the control group and 1 in the experimental group who underwent reoperation had an adhesion-evaluation score of 3 points. There were no adverse effects or allergic reactions.

Conclusion: A thermosensitive sol-gel agent can be safely used as an anti-adhesive barrier. However, this study did not reveal its efficacy for postoperative adhesions. A more objective and systematic study is required in the future.

Keywords: Prevention & control; Randomized controlled trial; Safety; Thyroidectomy; Tissue adhesions.

Fig. 1. Flow diagram of the randomized controlled trial. The thermosensitive sol-gel agent was applied to the surgical site in the Mediclore group. No anti-adhesive agent was applied to the surgical site. Mediclore: CGBio Co., Ltd. Seongnam, Korea.

Fig. 2. Comparison of swallowing difficulty by group and time. There was no difference in the degree of difficulty swallowing between the 2 groups based on the questionnaire survey of the postoperative adhesions at 2 weeks, 3 months, and 6 months after surgery. Mediclore: CGBio Co., Ltd. Seongnam, Korea.

Fig. 3. Comparison of inflammatory problems by group and time. There was no difference in the outcomes between the 2 groups when the wrinkle problems were assessed using the questionnaire for postoperative adhesions 2 weeks, 3 months, and 6 months after surgery. Mediclore: CGBio Co., Ltd. Seongnam, Korea.

Fig. 4. Comparison of wrinkle problems by group and time. There was no difference in the scores for inflammatory problems at 2 weeks, 3 months, and 6 months after surgery. Mediclore: CGBio Co., Ltd. Seongnam, Korea.