First-in-human Testing of a Novel Sutureless Drain Securement Device: A Randomized Clinical Trial

Area of Science:

• Surgical Innovation
• Medical Device Development
• Patient Comfort and Safety

Background:

• Traditional suture-based drain securement methods are non-standardized, leading to patient discomfort, skin irritation, and potential drain displacement.
• Risks associated with suture securement include pain, skin tugging, and unintended drain loss, necessitating alternative solutions.

Purpose of the Study:

• To evaluate the efficacy and patient experience of a novel sutureless drain securement device, K-LOCK, compared to traditional suture methods.
• To assess securement time, adverse outcomes, patient satisfaction, and skin site condition.

Main Methods:

• A randomized controlled trial involving 21 adult patients undergoing surgeries with bilateral drains was conducted.
• Patients received either K-LOCK securement or traditional suture securement on contralateral sides, with outcomes analyzed using paired t tests.

Main Results:

• K-LOCK securement was significantly faster than suture securement (P = 0.0008), with no securement failures.
• Blinded skin site evaluations showed no significant differences in erythema or blistering between K-LOCK and sutures.
• Patients overwhelmingly favored the K-LOCK device in all surveyed satisfaction categories.

Conclusions:

• The K-LOCK device provides a reliable, standardized, and comfortable alternative to traditional surgical drain securement.
• Further large-scale, multicenter trials are recommended to fully assess the long-term benefits of the K-LOCK device.