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

Suture-based drain securement is nonstandardized and causes discomfort, particularly at the site of fixation as drain movement is transmitted to a focal point. Patients may experience skin irritation, pain, skin tugging, and loosening or unintended loss of the drain. A novel sutureless drain securement device, K-LOCK, was designed with patient safety and comfort in mind to reduce risks associated with drain displacement and loss, potentially leading to complications or additional interventions.

After institutional review board approval, 21 patients were enrolled in a randomized control trial after obtaining informed consent. Inclusion criteria required patients to be 18 years of age or older and undergoing a surgery involving placement of bilateral drains. Those with adhesive allergies were excluded. Patients were randomized to receive a right or left K-LOCK with the contralateral site undergoing suture-based drain securement. Outcomes included time to secure drains, adverse outcomes, patient satisfaction, and a blinded evaluation of skin sites at drain removal. Analysis was performed using paired t tests.

No drain securement failure was encountered. The average duration of drain placement was 9 days. Securement of the K-LOCK was significantly faster (P = 0.0008) when compared with traditional suture. Blinded skin site evaluations concluded there was no significant difference in erythema and blistering (P = 0.9384, P = 0.6058, respectively). Patients overwhelmingly favored the K-LOCK in all surveyed categories.

The K-LOCK enhances the patient experience with surgical drains and offers a reliable, standardized alternative to traditional drain securement. Although these findings are promising, larger multicenter trials with long-term follow-up will be necessary to comprehensively assess the device.