Plastic and reconstructive surgery. Global open · 2025
First-in-human Testing of a Novel Sutureless Drain Securement Device: A Randomized Clinical Trial.
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Duet Mary L, Zeng Eric, Boyajian Michael K, Browne Donald T, Peoples Abigail, Tapp Marion, Siska Robert, Steele Thomas, Calder Bennett W, Runyan Christopher, David Lisa R
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.