Skin Injury
Conditions
Keywords
drain, suture, body contouring
Brief 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.
Detailed description
This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the sutureless drain securement device will be compared to the use of sutures to secure drains. 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.
Interventions
DEVICEK-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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time it Takes to Secure and Dress Each Drain in Totality | Day of Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use | Day of Surgery | 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. |
| Skin Injury | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 9 |
| Total | 22 |
Baseline characteristics
| Characteristic | B K-Lock Right | Total | A K-Lock Left |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 22 Participants | 13 Participants |
| Age, Continuous | 42.77777778 years STANDARD_DEVIATION 15.03144851 | 44.27272727 years STANDARD_DEVIATION 11.40251358 | 45.30769231 years STANDARD_DEVIATION 8.606050346 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 19 Participants | 11 Participants |
| Region of Enrollment United States | 9 participants | 22 participants | 13 participants |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 9 |
| other Total, other adverse events | 1 / 13 | 1 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 |
Outcome results
Primary
Time it Takes to Secure and Dress Each Drain in Totality
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.
Time frame: Day of Surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A K-Lock Left | Time it Takes to Secure and Dress Each Drain in Totality | Time to secure Suture and dress | 114 Seconds | Standard Deviation 0.018172119 |
| A K-Lock Left | Time it Takes to Secure and Dress Each Drain in Totality | Time to secure K-Lock and dress | 67 Seconds | Standard Deviation 0.013750872 |
| B K-Lock Right | Time it Takes to Secure and Dress Each Drain in Totality | Time to secure Suture and dress | 94 Seconds | Standard Deviation 0.012821128 |
| B K-Lock Right | Time it Takes to Secure and Dress Each Drain in Totality | Time to secure K-Lock and dress | 79 Seconds | Standard Deviation 0.031915706 |
Secondary
Ease of Use
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A K-Lock Left | Ease of Use | 4.553846154 score on a scale | Standard Deviation 0.224256939 |
Secondary
Skin Injury
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.
Time frame: On Average Day 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A K-Lock Left | Skin Injury | 1 Occurrence of skin injury |