Wound HealNCT03285542
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
A study testing DERMABOND and Staples in people with Wound Heal, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Heal
- What is being tested?
- DERMABOND and Staples
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Able to fluently speak and understand the local language
- If female, is nonpregnant (negative pregnancy test results at the baseline/randomization visit) and nonlactating.
- End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty
- BMI less than 40 kg/m2
Who cannot join
- BMI greater than or equal to 40 kg/m2
- History of known bleeding disorder
- History of medical co-morbidity that may result in poor wound healing (ie. diabetes mellitus, peripheral vascular disease)
- Patients <18 or >80 years of age
- Patients who are prisoners
- Mentally unable to sign informed consent
- Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of Dermabond Prineo Wound Closure System on Operating Room Time and Wound Closure Time in Total Knee Arthroplasty
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).
Read the 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.
- Conditions
- Wound Heal
- Being tested
- DERMABOND, Staples
- Keywords
- adhesive, total knee arthroplasty, wound, closure, time, barbed suture, knoteless suture
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DERMABONDDevice
DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)
StaplesDevice
staples for skin closure
| Study group | Role | What they receive |
|---|---|---|
| DERMABOND GROUP | Active comparator | 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. Receives: Device: DERMABOND |
| CONTROL GROUP | Placebo comparator | 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 Receives: Device: Staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days postoperative
Secondary outcomes (2)
Number of Patients With Wound Complications
presence of superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.
Measured: 90 days postoperative
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.
Measured: 90 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start15 Sep 2017
- Primary completion25 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Krebs, M.D., The Cleveland Clinic
- Investigators
- Viktor Krebs, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285542
- Sponsor's protocol ID
- 17-842
- Status last verified
- Apr 2021
- First submitted
- 14 Sep 2017
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Dermabond Prineo Wound Closure System on Operating Room Time and Wound Closure Time in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03285542
- Acronym / sponsor ID
- 17-842
- Conditions
- Wound Heal
- Keywords
- adhesive, total knee arthroplasty, wound, closure, time, barbed suture, knoteless suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DERMABOND GROUP | Active comparator | Device: DERMABONDFor 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. |
| CONTROL GROUP | Placebo comparator | Device: StaplesFor 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Able to fluently speak and understand the local language
- If female, is nonpregnant (negative pregnancy test results at the baseline/randomization visit) and nonlactating.
Key exclusion criteria (7 listed)
- BMI greater than or equal to 40 kg/m2
- History of known bleeding disorder
- History of medical co-morbidity that may result in poor wound healing (ie. diabetes mellitus, peripheral vascular disease)
- Patients <18 or >80 years of age
- Patients who are prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DERMABONDDERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) | Device | DERMABOND GROUP |
| Staplesstaples for skin closure | Device | CONTROL GROUP |
Primary outcome
Modified Hollander Cosmesis Scale
Time frame: 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).
2 secondary outcomes
Number of Patients With Wound Complications
Time frame: 90 days postoperative
Patient Satisfaction (Visual Analogue Scale)
Time frame: 90 days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Krebs, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DERMABOND and Staples in people with Wound Heal, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Hollander Cosmesis Scale (time frame: 90 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.