Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications

A Prospective, Randomized, Multi-center Trial Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Drain
• Intervention / Treatment: Device: K-Lock; Other: Suture

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renea D Jennings, BSN,RN,CCRP; Phone Number: 336-716-6709; Email: renea.jennings@advocatehealth.org
• Study Contact Backup: Name: Caleb T Suggs, CCRP; Phone Number: 336-713-4339; Email: caleb.suggs@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K-Lock Device; K-Lock securement device	Device: K-Lock; Surgical drain securement with a novel sutureless K-LOCK device
Active Comparator: Traditional Suture; Traditional suture securement	Other: Suture; Surgical drain securement with traditional suture-based methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome Measure Score	Patient reported outcome measures questionnaire will be completed by participant. Total score ranges from 6-30 with a higher score indicating a higher level of patient satisfaction.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complications	Number of complications including calls to triage nurse, visits to Emergency Room, requests for additional pain medication, early loss of drain.	Month 3
Rating of Drain Exit Sites	Questionnaire to be completed by a health care team member who is blinded to drain securement method. Drain site will be inspected for erythema, irritation, blistering, maceration, etc. and rated after removal of the drain. Ratings will range from 0-4 with higher rating indicating more severity.	Month 3

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: University of Mississippi Medical Center
• Investigators: Principal Investigator: Bennett W Calder, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Drain Insertion Site; Drain Site Complication; Plastic and Reconstructive Surgery
• Additional Relevant MeSH Terms: Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Sutures
• Other Study ID Numbers: IRB00128120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No