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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06916286
Status
Recruiting
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Conditions

  • Surgical Drain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • K-Lock — DEVICE
    Surgical drain securement with a novel sutureless K-LOCK device
  • Suture — OTHER
    Surgical drain securement with traditional suture-based methods

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
Feb 2026
Primary completion
May 30, 2027
Completion
May 30, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: K-Lock Device
    K-Lock securement device
  • Active Comparator: Traditional Suture
    Traditional suture securement

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

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Wake Forest University Health Sciences· Winston-Salem, NC

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