Evaluating a new device for securing surgical drains to improve patient outcomes
A Prospective, Randomized, Multi-center Trial Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06916286 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.