Cardiac Arrhythmia, Wound
Conditions
Keywords
pacemaker, implantable cardioverter defibrillator, ICD, surgical wound closure, sutures, Zipline, Zips, CIED, cardiovascular implantable electronic devices, arrhythmia
Brief summary
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called Zip Surgical Skin Closure to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin Closure to standard sutures in patients undergoing cardiovascular implantable electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting scar, and overall cosmetic appearance of scar. The study will be following participants for 3 months following CIED procedure.
Detailed description
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called Zip Surgical Skin Closure to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The device is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome.The ZIPS study is a randomized, clinical trial comparing outcomes of procedures that use the Zip Surgical Skin Closure device with the outcomes of procedures that use stitches. The Zip Surgical Skin Closure is not an investigational device and is currently used in hospital across the United States. The Zip Surgical Skin Closure is a non-invasive (in other words, does not pierce the skin or enter into the wound) device to hold skin closed while healing can occur. It adheres to the skin close to the incision and uses adjustable straps to hold the incision closed. It is typically worn on the skin for 7-14 days and is removed by peeling from the skin. Patients will be randomized to either Zip Surgical Skin Closure or sutures, in addition to dissolvable sutures for the deeper layers, for surgical procedures for cardiovascular implantable electronic devices (CIED) i.e. pacemakers or defibrillators. Both of these closure techniques are considered standard of care at this facility and are not themselves experimental. However, the goal of this experimental study is to see if there are any significant differences between the two closure methods, in a controlled study environment. Since the Zip Surgical Skin Closure device is relatively new to the market, there is a limited amount of information available describing the experience of patients and doctors using the device. In this study, the investigators will be looking to compare the Zip Surgical Skin Closure and stitches methods for the time necessary for the surgeon to close the incision, cosmetic appearance of the resulting scar, and satisfaction of you and your surgeon. The investigators will also be monitoring both study groups for occurrence of any adverse (unfavorable) events. Patients will be followed for a total of 3 months for this study. All study visits align with standard of care follow up for post-implantation of CIED. Non-identifiable pictures will be obtained of the scar during follow up and both patients and surgeons will complete questionnaires indicating their experience and satisfaction with the either skin closure method.
Interventions
The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
DEVICEStandard Suture Closure
The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Sponsors
ZipLine Medical Inc.
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years of age and older; 2. Patients requiring suture closure for epidermal closure (after placement of cardiac implantable electronic devices; including de novo and re implant generator changes); 3. Patients willing and able to complete study protocol 4. Life expectancy greater than 1 year
Exclusion criteria
1. Known bleeding disorder not caused by medication; 2. Known personal or family history of keloid formation or scar hypertrophy; 3. Known allergy or hypersensitivity to non-latex skin adhesives; 4. Atrophic skin deemed clinically prone to blistering; 5. Any skin disorder affecting wound healing; 6. Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study. 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Closure Time | 2 weeks | Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.) |
| Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale) | 3 Months | Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction With Scar | 3 months | At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable. Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial. |
| Patient Comfort | 2 weeks | At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable). |
| Surgeon Wound Evaluation Scale (WES) | 2 weeks | At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar). |
| Patient Rating of Scar | 3 months | At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar) Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial. |
| Patient Incision Pain | 1 day (discharge) | At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain). |
| Patient Satisfaction With Scar | 3 months | Patient will complete questionnaires that includes assessments of the following: 1. Pain 2. Closure Method Comfort 3. Closure Method Satisfaction 4. Scar Satisfaction Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied) Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial. |
| Surgeon Evaluation Based on the Wound Evaluation Scale (WES) | 3 Months | The surgeon will complete an assessment of the following: 1. Closure Method Satisfaction 2. Scar Satisfaction 3. Wound Healing as judged by Wound Evaluation Scale Scale rated on 1 (least favorable) to 6 (most favorable) Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zip Surgical Skin Closure Device The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check. | 21 |
| Standard Suture Closure The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure. | 19 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Standard Suture Closure | Zip Surgical Skin Closure Device |
|---|---|---|---|
| Age, Continuous | 70 years | 70 years | 71 years |
| Fitzpatrick Skin Scale 1 - Always burns, never tans | 2 participants | 0 participants | 2 participants |
| Fitzpatrick Skin Scale 2 - Usually burns, tans with difficulty | 2 participants | 1 participants | 1 participants |
| Fitzpatrick Skin Scale 3 - Somtimes mild burn, gradually tans | 13 participants | 6 participants | 7 participants |
| Fitzpatrick Skin Scale 4 - Rarely burns, tans with ease | 13 participants | 7 participants | 6 participants |
| Fitzpatrick Skin Scale 5 - Very rarely burns, tans very easily | 7 participants | 3 participants | 4 participants |
| Fitzpatrick Skin Scale 6 - Never burns, tans very easily | 3 participants | 2 participants | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 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 | 36 Participants | 17 Participants | 19 Participants |
| Region of Enrollment United States | 40 participants | 19 participants | 21 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 25 Participants | 12 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
Overall Closure Time
Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Overall Closure Time | 78 seconds | Standard Deviation 30.36 |
| Standard Suture Closure | Overall Closure Time | 216 seconds | Standard Deviation 93.71 |
p-value: <0.001t-test, 2 sided
Primary
Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)
Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).
Time frame: 3 Months
Population: Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale) | 35.8 mm | Standard Deviation 40.6 |
| Standard Suture Closure | Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale) | 40.6 mm | Standard Deviation 21.7 |
p-value: 0.655t-test, 2 sided
Secondary
Patient Comfort
At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Patient Comfort | 1.77 units on a scale | Standard Deviation 1.15 |
| Standard Suture Closure | Patient Comfort | 1.94 units on a scale | Standard Deviation 1.16 |
p-value: 0.646t-test, 2 sided
Secondary
Patient Incision Pain
At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).
Time frame: 1 day (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Patient Incision Pain | 1.77 units on a scale | Standard Deviation 2.48 |
| Standard Suture Closure | Patient Incision Pain | 2.15 units on a scale | Standard Deviation 1.83 |
p-value: 0.588t-test, 2 sided
Secondary
Patient Incision Pain
Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Patient Incision Pain | 0.27 units on a scale | Standard Deviation 0.41 |
| Standard Suture Closure | Patient Incision Pain | 0.27 units on a scale | Standard Deviation 0.73 |
p-value: 1t-test, 2 sided
Secondary
Patient Incision Pain
At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Patient Incision Pain | 0.64 units on a scale | Standard Deviation 0.92 |
| Standard Suture Closure | Patient Incision Pain | 0.71 units on a scale | Standard Deviation 1.41 |
p-value: 0.858t-test, 2 sided
Secondary
Patient Rating of Scar
At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar) Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Patient Rating of Scar | 0.87 units on a scale | Standard Deviation 0.76 |
| Standard Suture Closure | Patient Rating of Scar | 1.04 units on a scale | Standard Deviation 1.39 |
p-value: 0.651t-test, 2 sided
Secondary
Patient Satisfaction With Scar
Patient will complete questionnaires that includes assessments of the following: 1. Pain 2. Closure Method Comfort 3. Closure Method Satisfaction 4. Scar Satisfaction Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied) Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Patient Satisfaction With Scar | 1.32 units on a scale | Standard Deviation 0.48 |
| Standard Suture Closure | Patient Satisfaction With Scar | 1.22 units on a scale | Standard Deviation 0.43 |
p-value: 0.51t-test, 2 sided
Secondary
Surgeon Evaluation Based on the Wound Evaluation Scale (WES)
The surgeon will complete an assessment of the following: 1. Closure Method Satisfaction 2. Scar Satisfaction 3. Wound Healing as judged by Wound Evaluation Scale Scale rated on 1 (least favorable) to 6 (most favorable) Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Surgeon Evaluation Based on the Wound Evaluation Scale (WES) | 6 units on a scale | Standard Deviation 0 |
| Standard Suture Closure | Surgeon Evaluation Based on the Wound Evaluation Scale (WES) | 6 units on a scale | Standard Deviation 0 |
p-value: 1t-test, 2 sided
Secondary
Surgeon Satisfaction With Scar
At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable. Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Surgeon Satisfaction With Scar | 1 units on a scale | Standard Deviation 0 |
| Standard Suture Closure | Surgeon Satisfaction With Scar | 1.06 units on a scale | Standard Deviation 0.24 |
p-value: 0.462t-test, 2 sided
Secondary
Surgeon Wound Evaluation Scale (WES)
At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Surgical Skin Closure Device | Surgeon Wound Evaluation Scale (WES) | 5.82 units on a scale | Standard Deviation 0.5 |
| Standard Suture Closure | Surgeon Wound Evaluation Scale (WES) | 5.78 units on a scale | Standard Deviation 0.55 |
p-value: 0.811t-test, 2 sided