Clinical trial NCT06916286: Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications
Official title: A Prospective, Randomized, Multi-center Trial Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Drain
Keywords: Drain Insertion Site
Drain Site Complication
Plastic and Reconstructive Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2025-04-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

Brief 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.

Detailed 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 medications, unexpected drain removal, need for additional drain placement, etc. Subjects will return to clinic at their regularly scheduled follow-up appointments with no additional study related activities and will be followed by the study team weekly, via chart review for a total of 3 months from their surgery date. When the subjects return to clinic to have their final drain removed they will be asked to complete a survey asking about their experience with their drains and drain securement. We will also have a blinded evaluator complete a short survey evaluating the skin around the drain insertion site. Photos will be taken of the drain site upon drain removal and again at the 3 month follow-up visit.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Reported Outcome Measure Score
timeFrame: Month 3
Secondary outcomes:
measure: Number of Complications
timeFrame: Month 3
measure: Rating of Drain Exit Sites
timeFrame: Month 3
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bennett W Calder, MD
role: PRINCIPAL_INVESTIGATOR
References: