Arthroplasty, Knee Replacement, Wound Healing
Conditions
Keywords
bi lateral, knee surgery, arthroplasty, orthopedics
Brief summary
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
Detailed description
Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.
Interventions
Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
DEVICESteel Staples
Skin closure device for the closure of the skin layer following surgical incision
Sponsors
ZipLine Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients 18 years of age and older 2. Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty 3. Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op
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 patient unsuitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incision Appearance / Scar Cosmesis | 6-8 weeks post surgery | Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Closure Method Satisfaction | 6-8 weeks post op | Closure method satisfaction will be collected by a 5 point satisfaction scale: 1. Very Satisfied 2. Satisfied 3. Neither 4. Dissatisfied 5. Very Dissatisfied A lower score means more satisfaction with the closure method. |
| Patient Pain - Incisional and General | Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit) | Pain levels will be collected using a 10 point VAS scale. |
| Surgeon and Patient Scar Satisfaction | 6 to 8 wk follow up visit | Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied |
| Range of Motion | 2 weeks and 6-8 weeks | Knee Range of Motion for each knee will be measured in degrees |
Countries
United States
Participant flow
Recruitment details
This is a split person study where one knee is assigned Zip, the other knee is assigned Staples. 50 knees were closed on 25 participants.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.2 |
| Race/Ethnicity, Customized Black/African Amer. | 2 Participants |
| Race/Ethnicity, Customized White | 23 Participants |
| Range of Motion Knees assigned Staple closure | 118 degrees STANDARD_DEVIATION 25.99 |
| Range of Motion Knees assigned Zip closure | 121 degrees STANDARD_DEVIATION 13.66 |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 1 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Incision Appearance / Scar Cosmesis
Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.
Time frame: 6-8 weeks post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zip Surgical Skin Closure | Incision Appearance / Scar Cosmesis | Patient Rating | 1.3 units on a scale | Standard Deviation 0.5 |
| Zip Surgical Skin Closure | Incision Appearance / Scar Cosmesis | Surgeon Rating | 1.9 units on a scale | Standard Deviation 1.2 |
| Zip Surgical Skin Closure | Incision Appearance / Scar Cosmesis | Plastic Surgeon Rating | 3.7 units on a scale | Standard Deviation 2 |
| Steel Staples | Incision Appearance / Scar Cosmesis | Patient Rating | 2.6 units on a scale | Standard Deviation 2.4 |
| Steel Staples | Incision Appearance / Scar Cosmesis | Surgeon Rating | 3.3 units on a scale | Standard Deviation 1 |
| Steel Staples | Incision Appearance / Scar Cosmesis | Plastic Surgeon Rating | 4.8 units on a scale | Standard Deviation 1.8 |
Secondary
Patient Pain - Incisional and General
Pain levels will be collected using a 10 point VAS scale.
Time frame: Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)
Population: Patient incisional pain scores for Zip side and incisional pain scores for Staples side were collected (0=no pain, 10=worst pain imaginable)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zip Surgical Skin Closure | Patient Pain - Incisional and General | Discharge Pain | 1.8 units on a scale | Standard Deviation 2 |
| Zip Surgical Skin Closure | Patient Pain - Incisional and General | 2 Week Pain pre removal | 1.4 units on a scale | Standard Deviation 1.7 |
| Zip Surgical Skin Closure | Patient Pain - Incisional and General | 2 Week Pain post removal | 0.7 units on a scale | Standard Deviation 1.1 |
| Zip Surgical Skin Closure | Patient Pain - Incisional and General | 6 to 8 Week Pain | 0.5 units on a scale | Standard Deviation 0.1 |
| Steel Staples | Patient Pain - Incisional and General | 6 to 8 Week Pain | 0.9 units on a scale | Standard Deviation 1.4 |
| Steel Staples | Patient Pain - Incisional and General | Discharge Pain | 2.4 units on a scale | Standard Deviation 2.6 |
| Steel Staples | Patient Pain - Incisional and General | 2 Week Pain post removal | 1.6 units on a scale | Standard Deviation 1.2 |
| Steel Staples | Patient Pain - Incisional and General | 2 Week Pain pre removal | 2.0 units on a scale | Standard Deviation 1.8 |
Secondary
Range of Motion
Knee Range of Motion for each knee will be measured in degrees
Time frame: 2 weeks and 6-8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zip Surgical Skin Closure | Range of Motion | 2 week Range of Motion | 109 degrees | Standard Deviation 11.79 |
| Zip Surgical Skin Closure | Range of Motion | 6-8 Week Range of Motion | 122 degrees | Standard Deviation 10.78 |
| Steel Staples | Range of Motion | 2 week Range of Motion | 105 degrees | Standard Deviation 13.64 |
| Steel Staples | Range of Motion | 6-8 Week Range of Motion | 122 degrees | Standard Deviation 10.82 |
Secondary
Surgeon and Patient Scar Satisfaction
Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied
Time frame: 6 to 8 wk follow up visit
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Neither | 1 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Very Satisfied | 18 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Satisfied | 7 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Satisfied | 4 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Neither | 3 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Dissatisfied | 0 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Dissatisfied | 0 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Very Satisfied | 17 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Very Dissatisfied | 0 Participants |
| Zip Surgical Skin Closure | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Very Dissatisfied | 0 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Very Dissatisfied | 0 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Very Satisfied | 5 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Satisfied | 17 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Neither | 3 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Dissatisfied | 0 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Surgeon Scar Satisfaction | Very Dissatisfied | 0 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Very Satisfied | 8 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Neither | 7 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Dissatisfied | 3 Participants |
| Steel Staples | Surgeon and Patient Scar Satisfaction | Patient Scar Satisfaction | Satisfied | 7 Participants |
Secondary
Surgeon Closure Method Satisfaction
Closure method satisfaction will be collected by a 5 point satisfaction scale: 1. Very Satisfied 2. Satisfied 3. Neither 4. Dissatisfied 5. Very Dissatisfied A lower score means more satisfaction with the closure method.
Time frame: 6-8 weeks post op
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zip Surgical Skin Closure | Surgeon Closure Method Satisfaction | Surgeon Neither Satisfied or Dissatisfied | 1 Participants |
| Zip Surgical Skin Closure | Surgeon Closure Method Satisfaction | Surgeon Very Satisfied | 17 Participants |
| Zip Surgical Skin Closure | Surgeon Closure Method Satisfaction | Surgeon Satisfied | 7 Participants |
| Steel Staples | Surgeon Closure Method Satisfaction | Surgeon Neither Satisfied or Dissatisfied | 3 Participants |
| Steel Staples | Surgeon Closure Method Satisfaction | Surgeon Very Satisfied | 5 Participants |
| Steel Staples | Surgeon Closure Method Satisfaction | Surgeon Satisfied | 17 Participants |