Evaluating a new device for securing surgical drains to improve patient outcomes
Official title: A Prospective, Randomized, Multi-center Trial Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications
Run by Wake Forest University Health Sciences · NCT06916286 · Data updated 2026-11-12
This study is testing a new device called K-LOCK™ to see if it can better secure surgical drains and improve recovery for patients after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | May 5, 2025 |
| Main results expected | May 30, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT06916286 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing surgical procedures requiring one or more drains in the Department of Plastic and Reconstructive Surgery.
✕Probably not a fit
Patients who cannot consent in English, have incompatible drain sizes, or have allergies to skin adhesives may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness of a novel sutureless device, K-LOCK™, in securing surgical drains compared to traditional suture methods. Patients undergoing surgery with anticipated drain placement will be randomly assigned to either the K-LOCK™ group or the suture group. Postoperative follow-up will include monitoring for complications and quality of life through surveys and medical record reviews over a three-month period. The goal is to determine if the K-LOCK™ device enhances patient experiences and reduces complications associated with surgical drains.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient quality of life and reduce complications related to surgical drains.
How similar studies have gone: While the use of sutureless devices is gaining interest, this specific approach with the K-LOCK™ device is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Bennett W Calder, MD — Wake Forest University Health Sciences
- Study coordinator: Renea D Jennings, BSN,RN,CCRP
- Email: renea.jennings@advocatehealth.org
- Phone: 336-716-6709
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.