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NCT Number: NCT06916286

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-Lock

Device

Surgical drain securement with a novel sutureless K-LOCK device

Suture

Other

Surgical drain securement with traditional suture-based methods

Primary outcomes

  1. Patient-Reported Outcome Measure Score

    Time frame: 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 outcomes

  1. Number of Complications

    Time frame: Month 3

    Number of complications including calls to triage nurse, visits to Emergency Room, requests for additional pain medication, early loss of drain.

  2. Rating of Drain Exit Sites

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caleb T Suggs, CCRP

CONTACT

[email protected]

336-713-4339

Renea D Jennings, BSN,RN,CCRP

CONTACT

[email protected]

336-716-6709

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • University of Mississippi Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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