N/A
N=22
Evaluation of a Novel Sutureless Drain Securement Device
Skin Injury
Bottom Line
View on ClinicalTrials.gov: NCT05251753 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Time it Takes to Secure and Dress Each Drain in Totality — 67; 79; 114; 94 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- K-Lock (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time it Takes to Secure and Dress Each Drain in Totality |
67; 79; 114; 94 | — |
| SECONDARY Ease of Use |
4.553846154 | — |
| SECONDARY Skin Injury |
1 | — |
Summary
The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Patient of the Department of Plastic and Reconstructive Surgery
- Able to sign English language Consent form
- Undergoing any of the following procedures requiring placement of 2 or more drains (preferably bilateral) including: Breast reconstruction, Bilateral Breast Reduction, Abdominoplasty, Body Contour surgery (e.g. panniculectomy, brachiplasty, thighplasty)
Exclusion Criteria
- Patients with unilateral drain placement
- Unable to sign English language consent form
- Allergy to Tegaderm Dressing
Data sourced from ClinicalTrials.gov (NCT05251753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.