A Prospective, Randomized, Multi-center Trial Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications
Wake Forest University Health Sciences
Summary
The objective of this study is to evaluate whether surgical drain securement with a novel sutureless device (K-LOCKTM) will improve patient quality of life and reduce postoperative drain-related complications compared to drain securement with traditional suture-based methods. The K-LOCK™ Device is a novel sutureless drain securement device that may improve patient experiences with surgical drains.
Description
Patients will be identified as potential subjects where the study team will speak with them, determine eligibility, and obtain consent prior to surgery. On the day of surgery, patients will be randomized to either A) drains being secured with the K-Lock device or B) drains being secured with the suture-based technique. All drains will be secured according to randomization. Postoperatively: The study team will follow the subjects weekly via the electronic medical record documenting (in REDCap) calls made to the triage nurse, visits to the emergency department, requests for additional pain medi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or older * Patient of the Department of Plastic and Reconstructive Surgery * Able to sign English language Consent form * Undergoing a surgical procedure where placement of one or more surgical drains is anticipated Exclusion Criteria: * Unable to sign English language consent form * Incompatible drain size placed * Allergy or sensitivity to skin adhesives
Interventions
- DeviceK-Lock
Surgical drain securement with a novel sutureless K-LOCK device
- OtherSuture
Surgical drain securement with traditional suture-based methods
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina