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

NCT06916286 | Recruiting FDA Device

• 1 other identifier: IRB00128120
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Drain

Keywords

Drain Insertion Site; Drain Site Complication; Plastic and Reconstructive Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Complications

  Month 3

• Rating of Drain Exit Sites

  Month 3

Study Arms (2)

K-Lock Device

EXPERIMENTAL

K-Lock securement device

Device: K-Lock

Traditional Suture

ACTIVE COMPARATOR

Traditional suture securement

Other: Suture

Interventions

K-Lock DEVICE

Surgical drain securement with a novel sutureless K-LOCK device

K-Lock Device

Suture OTHER

Surgical drain securement with traditional suture-based methods

Traditional Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to sign English language consent form
• Incompatible drain size placed
• Allergy or sensitivity to skin adhesives

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of Mississippi Medical Center: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Bennett W Calder, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renea D Jennings, BSN,RN,CCRP

CONTACT

336-716-6709; renea.jennings@advocatehealth.org

Caleb T Suggs, CCRP

CONTACT

336-713-4339; caleb.suggs@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)