Trial Outcomes & Findings for Evaluation of a Novel Sutureless Drain Securement Device (NCT NCT05251753)

Last Updated: 2025-05-20

Results Overview

Time it takes to secure and dress each drain will be evaluated in totality by evaluation of video recordings to record timestamps and documented on "K-Lock Study Outcomes" tool. This will help determine the feasibility of using this device.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Day of Surgery

Results posted on

2025-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	A K-Lock Left A) left side K-Lock with right side suture-based technique K-Lock: 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.	B K-Lock Right B) right side K-Lock with left side suture-based technique. K-Lock: 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.
Overall Study STARTED	13	9
Overall Study COMPLETED	13	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Novel Sutureless Drain Securement Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A K-Lock Left n=13 Participants A) left side K-Lock with right side suture-based technique K-Lock: 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.	B K-Lock Right n=9 Participants B) right side K-Lock with left side suture-based technique. K-Lock: 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.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.30769231 years STANDARD_DEVIATION 8.606050346 • n=5 Participants	42.77777778 years STANDARD_DEVIATION 15.03144851 • n=7 Participants	44.27272727 years STANDARD_DEVIATION 11.40251358 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	9 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of Surgery

Outcome measures

Outcome measures
Measure	A K-Lock Left n=13 Participants A) left side K-Lock with right side suture-based technique K-Lock: 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.	B K-Lock Right n=9 Participants B) right side K-Lock with left side suture-based technique. K-Lock: 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.
Time it Takes to Secure and Dress Each Drain in Totality Time to secure K-Lock and dress	67 Seconds Standard Deviation 0.013750872	79 Seconds Standard Deviation 0.031915706
Time it Takes to Secure and Dress Each Drain in Totality Time to secure Suture and dress	114 Seconds Standard Deviation 0.018172119	94 Seconds Standard Deviation 0.012821128

SECONDARY outcome

Timeframe: Day of Surgery

Population: Surgeons were assessed for this Outcome Measure but were not enrolled in the study. It was pre-specified to collect and report the scores for the K-Lock device itself, regardless of left or right. Individual surgeons performed surgery on more than one participant which explains why the number of surgeries is higher than the number of surgeons (overall number of participants analyzed).

For each participant, the surgeon will evaluate the K-Lock device ease of use of on a scale from 1-5. A higher score indicates greater ease of use.

Outcome measures

Outcome measures
Measure	A K-Lock Left n=13 surgeries A) left side K-Lock with right side suture-based technique K-Lock: 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.	B K-Lock Right B) right side K-Lock with left side suture-based technique. K-Lock: 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.
Ease of Use	4.553846154 score on a scale Standard Deviation 0.224256939	—

SECONDARY outcome

Timeframe: On Average Day 10

Skin Injury will be evaluated by inspecting device sites for instances of skin injury at each office visit and will be recorded on "K-Lock Study Outcomes" tool. Skin Injury will also be evaluated by quantitative feedback obtained in the "Drain Securement Survey" given to patients post-operatively. Number of Injuries for all K-Lock sites will be reported as a total.

Outcome measures

Outcome measures
Measure	A K-Lock Left n=22 K-Lock Drain Sites A) left side K-Lock with right side suture-based technique K-Lock: 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.	B K-Lock Right B) right side K-Lock with left side suture-based technique. K-Lock: 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.
Skin Injury	1 Occurrence of skin injury	—

Adverse Events

A K-Lock Left

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

B K-Lock Right

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	A K-Lock Left n=13 participants at risk A) left side K-Lock with right side suture-based technique	B K-Lock Right n=9 participants at risk B) right side K-Lock with left side suture-based technique.
Surgical and medical procedures Device became loose	7.7% 1/13 • Number of events 1 • 3 months Reported all Adverse Events within 24 hours of becoming aware.	0.00% 0/9 • 3 months Reported all Adverse Events within 24 hours of becoming aware.
Surgical and medical procedures Hematoma	0.00% 0/13 • 3 months Reported all Adverse Events within 24 hours of becoming aware.	11.1% 1/9 • Number of events 1 • 3 months Reported all Adverse Events within 24 hours of becoming aware.

Additional Information

Caleb Suggs

Wake Forest School of Medicine

Phone: 3367164171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place