Wound Heal
Conditions
Keywords
adhesive, total knee arthroplasty, wound, closure, time, barbed suture, knoteless suture
Brief summary
In this prospective pilot study examining the superficial closure during total knee arthroplasty, active subjects will receive the STRATAFIX Spiral Knotless Tissue Control Device for subcuticular closure in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. The control subjects will receive staples (standard-of-care).
Detailed description
The DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system is a unique two-part skin closure system that consists of: a 2-octyl cyanoacrylate topical skin adhesive for proven strength and microbial protection in vitro, and a flexible, self-adhesive polyester mesh for excellent approximation and healing. It is aimed to add strength and protection when closing medium to long incisions. In addition, it is designed to replace the use of subcuticular sutures or staples, with greater holding strength, with the potential to reduce skin closure time. Various studies have evaluated the outcomes of different closure devices, however, there are no reports assessing the length of closure times using DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during superficial closure in orthopaedic surgery. Huemer et al. (1) performed an observational study of 180 patients who had 224 excisional body-contouring surgeries utilizing Dermabond Prineo for superficial closure. Authors concluded that this closure type enables the surgeon to perform a quick and smooth skin closure. However, 4 patients (1.8%) developed local allergic reactions, which necessitated early removal and topical corticosteroid treatment. Parvizi et al.(2) performed an open, prospective, randomized clinical study of superficial wound closure on 60 patients undergoing abdominoplasty with either Dermabond Prineo or conventional superficial closure. They found significantly lower price ($134.79 cheaper) and significantly better Hollander Cosmesis Scale scores in Dermabond Prineo cohort. In addition, there was a significantly better cosmetic outcome at 6 and 12 months after surgery. The use of Dermabond Prineo may be able to decrease operative time and costs in other surgical fields, such as orthopedics. Careful patient allergy history is necessary to avoid adhesive allergic reactions.
Interventions
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document. 2. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Able to fluently speak and understand the local language 5. If female, is nonpregnant (negative pregnancy test results at the baseline/randomization visit) and nonlactating. 6. End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty 7. BMI less than 40 kg/m2
Exclusion criteria
1. BMI greater than or equal to 40 kg/m2 2. History of known bleeding disorder 3. History of medical co-morbidity that may result in poor wound healing (ie. diabetes mellitus, peripheral vascular disease) 4. Patients \<18 or \>80 years of age 5. Patients who are prisoners 6. Mentally unable to sign informed consent 7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Hollander Cosmesis Scale | 90 days postoperative | Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars. Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Wound Complications | 90 days postoperative | presence of superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence. |
| Patient Satisfaction (Visual Analogue Scale) | 90 days postoperative | patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DERMABOND GROUP For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) | 30 |
| CONTROL GROUP For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples
Staples: staples for skin closure | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | DERMABOND GROUP | CONTROL GROUP | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 7 | 62 years STANDARD_DEVIATION 8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 15 Participants | 37 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 2 / 30 | 0 / 30 |
Outcome results
Primary
Modified Hollander Cosmesis Scale
Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars. Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).
Time frame: 90 days postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DERMABOND GROUP | Modified Hollander Cosmesis Scale | Total score 0 | 30 Participants |
| DERMABOND GROUP | Modified Hollander Cosmesis Scale | Total score 1 | 0 Participants |
| DERMABOND GROUP | Modified Hollander Cosmesis Scale | Total score 2 | 0 Participants |
| DERMABOND GROUP | Modified Hollander Cosmesis Scale | Total score 3 | 0 Participants |
| DERMABOND GROUP | Modified Hollander Cosmesis Scale | Total score 4 | 0 Participants |
| DERMABOND GROUP | Modified Hollander Cosmesis Scale | Total score 5 | 0 Participants |
| CONTROL GROUP | Modified Hollander Cosmesis Scale | Total score 4 | 1 Participants |
| CONTROL GROUP | Modified Hollander Cosmesis Scale | Total score 0 | 0 Participants |
| CONTROL GROUP | Modified Hollander Cosmesis Scale | Total score 3 | 1 Participants |
| CONTROL GROUP | Modified Hollander Cosmesis Scale | Total score 1 | 23 Participants |
| CONTROL GROUP | Modified Hollander Cosmesis Scale | Total score 5 | 0 Participants |
| CONTROL GROUP | Modified Hollander Cosmesis Scale | Total score 2 | 5 Participants |
Secondary
Number of Patients With Wound Complications
presence of superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.
Time frame: 90 days postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DERMABOND GROUP | Number of Patients With Wound Complications | 2 Participants |
| CONTROL GROUP | Number of Patients With Wound Complications | 0 Participants |
Secondary
Patient Satisfaction (Visual Analogue Scale)
patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high.
Time frame: 90 days postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DERMABOND GROUP | Patient Satisfaction (Visual Analogue Scale) | 97.6 millimeters | Standard Deviation 3.2 |
| CONTROL GROUP | Patient Satisfaction (Visual Analogue Scale) | 82.6 millimeters | Standard Deviation 12.8 |