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

Not Applicable

Not yet recruiting

• Conditions: Surgical Drain

• Registration Number: NCT06916286
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Study Start: 2025-05-01
• Primary Completion: 2027-05-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcome Measure Score	Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Number of Complications	Month 3	Number of complications including calls to triage nurse, visits to Emergency Room, requests for additional pain medication, early loss of drain.
Rating of Drain Exit Sites	Month 3	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States