Evaluation of a Novel Sutureless Drain Securement Device (K-Lock Device) and Comparison to Standard Suture-based Drain Securement Techniques
Phase: NA
Conditions: Skin Injury
Sponsor: Wake Forest University Health Sciences

Official Title:  Evaluation of a Novel Sutureless Drain Securement Device (K-Lock Device) and Comparison 
to Standard Suture-based Drain Securement Techniques
NCT05251753
IRB Approval Date:  11/09/2023

 
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Study Title: Evaluation of a Novel Sutureless Drain Securement Device (K-Lock 
Device) and Comparison to Standard Suture-based Drain Securement Techniques 
 
Principal Investigator:  Lisa David, MD, MBA 
Co-investigator(s): Adam Katz, MD, Cassandra Driscoll, MD 
 
Sponsor or funding source: Department of Plastic and Reconstructive Surgery  
 
BACKGROUND, RATIONALE AND CONTEXT:  
Surgical drains are used in a variety of surgical specialties and procedures. Drains are placed prior to 
closing the operative wound, and serve to allow draining of bodily fluids that would otherwise fill the 
new potential space created during an operation. Though there are various drain designs, the core 
structure of a drain involves tubing placed in the wound, exiting through the skin, and attached to a 
collection device that uses negative pressure to allow drainage of serosangunious or other fluids produced 
at the drain site.  
 
To prevent the premature removal of surgical drains, the tubing is traditionally attached to the skin at the 
drain exit point using a suture. The suture is passed through the skin and then tied and wrapped around 
the tubing multiple times in a variety of patterns to hold the drain in place but not so tight as to occlude 
the tubing. When the suture is wrapped around the tubing multiple times over a distance, the technique is 
often referred to as the “Roman garter (RG) technique.”  
 
Traditional suture-based drain 
fixation is known to cause 
significant patient discomfort, 
predominantly at the site of skin 
suture fixation, where any pull on 
the drain tubing is transmitted to 
a focal point on the skin. Over 
time, this can result in significant 
skin irritation, inflammation and 
pain, skin erosion, loosening of 
the drain, suture failure, and 
possibly even early, unintended 
loss of the drain. Early loss of a 
drain, in turn, can lead to 
complications of seroma and/or 
infected abscess. In a survey of 
40 Wake Forest Plastic Surgery 
Patients with drains, patients 
were 
asked 
to 
rate 
their 
experience with surgical drains 
compared to their expectations on 
a sliding scale. The majority of 
patients reported experiences that 
were worse than or as expected 
(Figure 1). When specifically 
asked about irritation at the drain 
site, 33 of 40 patients rated 
comfort and pain as worse than 

 
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or as expected (Figure 2). With the known negative patient experiences associated with suture-based drain 
securement, there is a need for novel drain securement techniques and devices that can improve patient 
comfort and drain security.  
 
The K-Lock Device is a novel sutureless drain securement device that may improve patient experiences 
with surgical drains. The K-Lock Device is an FDA Class I device exempt from 510k requirements. 
 
OBJECTIVES: 
To evaluate the feasibility, safety and efficacy of a novel suture-less drain securement device (K-Lock) 
via direct comparison to suture-based techniques. 
 
To evaluate patient satisfaction with their surgical drain sites post operatively. 
 
DESIGN: 
Randomized controlled trial  
 
SETTING: 
Academic Medical Center 
 
SUBJECTS SELECTION 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 
 
 
Allergy to skin adhesives 
 
 
 
SAMPLE SIZE:  
We plan to enroll 40 patients allowing analysis of 80 (20 paired) drain sites: 40 prototype drain 
securement sites and 40 suture-based drain securement sites.  
 
INTERVENTIONS AND INTERACTIONS:  
Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) 
right side K-Lock with left side suture-based technique. Randomization will occur before study initiation 
with group A or group B being assigned to a study enrollment number.  
 
Preoperatively:  
The novel suture-less prototype device will be described and/or demonstrated to the patients, and the 
rationale for its development will be explained. They will have opportunity to ask questions and then 
they will be invited to participate in the study.  
 

 
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Written informed consent will be obtained.  
 
Intraoperatively:  
Surgical drains will be placed per the usual routine of the surgeon. However, prior to definitive 
fixation, the drains will be temporarily secured to the skin with a towel clamp and covered and/or 
positioned out of the way to allow for closure of surgical incisions. Definitive drain fixation will 
occur when all of the pertinent incisions are closed and dressed. At that time, each drain will be 
secured according to the randomization scheme. 
 
The amount of time it takes to secure and dress each drain will be recorded using a time-stamped 
video (e.g. iphone). No identifying data/information will be recorded, only the zoomed field pertinent 
to drain securement. For the prototype drain securement device, the ‘video clock’ will be started when 
the device is passed to the surgeon and stopped when the device/dressing is attached in place. For the 
standard suture-based technique, the ‘video clock’ will be started when the suture is passed to the 
surgeon and will be stopped when the dressing has been placed and secured. Use of a Biopatch with 
the drain will be up to the surgeon’s preference. The standard dressing for the suture-based techniques 
will include a split 4 x 4 dressing covered with a tegaderm. All dressing materials must be ready and 
available prior to handing the surgeon the suture/device.  
 
Postoperatively:  
The time until drain removal will be recorded for both groups.  
 
On postoperative visit(s) on which a drain is removed, patients will complete a survey about their 
experience with the pertinent securement method/drain site. 
 
Feasibility and ease of use of the novel drain device will be evaluated by evaluation of video 
recordings, qualitative feedback obtained from surgeons and/or O.R staff and nurses that handle and 
observe use of the device. Any failed application of the device will specifically be noted. In the event 
that a test device will need to be replaced for continued drain securement because the device has 
become loose or otherwise fouled, the replacement process will be performed by clinic staff using the 
IFU for such, and will be video recorded  
 
Safety of the novel drain device will be evaluated by inspecting device sites for instances of skin 
irritation at each office visit and at the time of drain removal, including photographs of drain sites 
immediately before and after removal. It will also be assessed by feedback obtained in the patient 
surveys. 
 
 
Postoperative review of patient charts will collect the following information up to 1 month from the 
removal of a subject’s final drain:  
• 
Date of drain removal (i.e. duration of drain) 
• 
Accidental vs Planned drain removal 
• 
Loosening of the drain 
• 
Any need for new device/new suture material to secure drain 
• 
Reinsertion of drain 
• 
Patient calls to triage regarding drain issues/concerns and the estimated or actual time/effort 
devoted to each issue/concern by clinic staff 
• 
Photos of the drain site at time of removal 
 

 
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As a follow-up to previous study activities, subjects will be contacted either by phone or at future 
clinic visits to gauge their interest in further participation. Subjects will be asked to have pictures 
taken of their drain sites and to fill out a survey to measure their satisfaction with their surgical drain 
sites further out from their procedures. Pictures will be attained at a scheduled research visit or a 
regular clinic visit if possible. A blinded evaluator will view the photos to assess in addition to the 
subject’s self-reported outcomes. The tool the subjects will complete is the Patient and Observer Scar 
Assessment Scale (POSAS). 
 
 
 
 
OUTCOME MEASURES: 
Primary: 
Feasibility 
 
Secondary: 
Safety 
Satisfaction 
 
 
ANALYTICAL PLAN: 
Results will be analyzed initially using descriptive statistics.  Comparison between groups will be done 
using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables.  
Regression analysis will be performed to identify independent outcome predictors.  Other inferential 
statistical analysis will be conducted as appropriate. 
 
HUMAN SUBJECTS PROTECTION: 
Patient-identifying information will be limited to what is necessary to conduct retrospective analysis and 
longitudinal analysis of drain securement that is accurately linked to a given subject. MRN and DOB will 
be captured to ensure data about a subject’s drain is accurately recorded during chart review. Other than 
the master ‘linkage’ file, patient names, DOB, and medical record numbers will be removed and subjects 
will be associated with an abstracted unique Study ID. Data will be stored electronically on the Wake 
Forest School of Medicine’s secure REDCap server, a HIPAA-compliant web platform.   
 
Information for each subject will be entered directly from EPIC to the secure REDCap database, so data 
will not be stored on portable storage devices (including thumb drives).  
 
 
SUBJECT RECRUITMENT METHODS: 
Patients will be identified by review of the departmental surgery schedule with study team members and 
identifying patients undergoing eligible surgical procedures.  
 
For the follow-up portion, subjects will be contacted either by phone or at future clinic visits to gauge 
their interest in further participation. 
 
INFORMED CONSENT:  
Signed informed consent will be obtained from each subject. Study coordinators and/or study 
investigators will obtain consent at either clinic appointments or during preoperative intake. Subjects 

 
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being consented during preoperative intake will be contacted prior to their visit by phone and will 
undergo a phone screening.  
 
 
CONFIDENTIALITY AND PRIVACY: 
Confidentiality will be protected by collecting only information needed to conduct outcomes research and 
related research to improve breast reduction outcomes. All database data will be entered into the Wake 
Forest School of Medicine’s secure REDCap server. To help ensure subject privacy and confidentiality, a 
linkage file will be maintained containing each patient’s medical record number and unique REDCap ID. 
Patient names will not be maintained in this file. The linkage file will be stored separately from the data 
available to researchers and will be kept secure, with access limited to designated study personnel. Data 
access will be limited to study staff.  Data and records will be kept locked and secured, with any computer 
data password protected.  No reference to any individual participant will appear in reports, presentations, 
or publications that may arise from the study. Following data collection subject identifying information 
will be destroyed, within three years of closure of the study. 
 
 
DATA AND SAFETY MONITORING: 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. 
 
 
REPORTING OF UNANTICIPATED PROBLEMS, ADVERSE EVENTS 
OR DEVIATIONS:  
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will 
be promptly reported by the principal investigator or designated member of the research team to the IRB 
and sponsor or appropriate government agency if appropriate. 
 
APPENDIX: 
1. Patient Survey 
2. Consent Form 
3. K-Lock Informational Sheet 
4. K-Lock Instructions for Use