Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06916286

Conditions

Surgical Drain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

K-Lock

Suture

Study Details

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

Study ID

NCT06916286

Start date

May 5, 2025

Status verified date

Feb, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: K-Lock Device

K-Lock securement device

active comparator: Traditional Suture

Traditional suture securement

Interventions

K-Lock

Surgical drain securement with a novel sutureless K-LOCK device

Suture

Surgical drain securement with traditional suture-based methods

Primary outcome measure

  • Patient-Reported Outcome Measure Score [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Renea D Jennings, BSN,RN,CCRP

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

Caleb T Suggs, CCRP

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

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-02-25.