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

NCT ID: NCT06916286

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2027-05-30

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.

Conditions

Surgical Drain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

K-Lock Device

K-Lock securement device

Group Type: EXPERIMENTAL

K-Lock

Intervention Type: DEVICE

Surgical drain securement with a novel sutureless K-LOCK device

Traditional Suture

Traditional suture securement

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: OTHER

Surgical drain securement with traditional suture-based methods

Interventions

K-Lock

Surgical drain securement with a novel sutureless K-LOCK device

Intervention Type: DEVICE

Suture

Surgical drain securement with traditional suture-based methods

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bennett W Calder, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Renea D Jennings, BSN,RN,CCRP

Role: CONTACT

rjenning@wakehealth.edu

336-716-6709

Caleb T Suggs, CCRP

Role: CONTACT

csuggs@wakehealth.edu

336-713-4339

Other Identifiers

IRB00128120

Identifier Type: -

Identifier Source: org_study_id