Trial Outcomes & Findings for ZIPS Study - Zip Incision aPproximation vs. Suture (NCT NCT02213510)

NCT ID: NCT02213510

Last Updated: 2016-05-30

Results Overview

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.)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2016-05-30

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	21	19
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

ZIPS Study - Zip Incision aPproximation vs. Suture

Baseline characteristics by cohort

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=19 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	71 years n=5 Participants	70 years n=7 Participants	70 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	17 Participants n=7 Participants	36 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	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Fitzpatrick Skin Scale 1 - Always burns, never tans	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Fitzpatrick Skin Scale 2 - Usually burns, tans with difficulty	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Fitzpatrick Skin Scale 3 - Somtimes mild burn, gradually tans	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Fitzpatrick Skin Scale 4 - Rarely burns, tans with ease	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Fitzpatrick Skin Scale 5 - Very rarely burns, tans very easily	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Fitzpatrick Skin Scale 6 - Never burns, tans very easily	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.)

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=19 Participants 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.
Overall Closure Time	78 seconds Standard Deviation 30.36	216 seconds Standard Deviation 93.71

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=18 Participants 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.
Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)	35.8 mm Standard Deviation 40.6	40.6 mm Standard Deviation 21.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=19 Participants 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.
Surgeon Wound Evaluation Scale (WES)	5.82 units on a scale Standard Deviation 0.50	5.78 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=18 Participants 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.
Surgeon Evaluation Based on the Wound Evaluation Scale (WES)	6 units on a scale Standard Deviation 0	6 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=18 Participants 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.
Surgeon Satisfaction With Scar	1 units on a scale Standard Deviation 0	1.06 units on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: 2 weeks

At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=19 Participants 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.
Patient Comfort	1.77 units on a scale Standard Deviation 1.15	1.94 units on a scale Standard Deviation 1.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=18 Participants 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.
Patient Satisfaction With Scar	1.32 units on a scale Standard Deviation 0.48	1.22 units on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=18 Participants 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.
Patient Rating of Scar	0.87 units on a scale Standard Deviation 0.76	1.04 units on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=19 Participants 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.
Patient Incision Pain	1.77 units on a scale Standard Deviation 2.48	2.15 units on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: 2 weeks

At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=19 Participants 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.
Patient Incision Pain	0.64 units on a scale Standard Deviation 0.92	0.71 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: 3 months

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).

Outcome measures

Measure	Zip Surgical Skin Closure Device n=21 Participants 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.	Standard Suture Closure n=18 Participants 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.
Patient Incision Pain	0.27 units on a scale Standard Deviation 0.41	0.27 units on a scale Standard Deviation 0.73

Adverse Events

Zip Surgical Skin Closure Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Suture Closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ulrika Birgersdotter-Green, MD

UC San Diego School of Medicine

Phone: 858-657-5310

Email: ubgreen@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place