First-in-human Testing of a Novel Sutureless Drain Securement Device: A Randomized Clinical Trial
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...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2025-06-01
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| Series: | Plastic and Reconstructive Surgery, Global Open |
| Online Access: | http://journals.lww.com/prsgo/fulltext/10.1097/GOX.0000000000006888 |
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| Summary: | 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. |
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| ISSN: | 2169-7574 |