OsteoarthritisNCT05173519
Omnibond vs Dermabond
A study testing Omnibond Topical Skin Adhesive and Dermabond Advanced Topical Skin Adhesive in people with Osteoarthritis, run by Center for Innovation and Research Organization at 4 sites in United States.
Trial summary
This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Omnibond Topical Skin Adhesive and Dermabond Advanced Topical Skin Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Oct 2022to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
- Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
- Subjects deemed able to understand and comply with study visit schedule and procedures
Who cannot join
- Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery
- Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
- Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
- Subjects who have participated in this trial previously and who were withdrawn
- Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
- Inability or refusal to provide informed consent or follow study and wound care instructions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
JIS Orthopaedics
New Albany, Ohio, 43054
Columbia University
New York, New York, 10032
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Prospective, Randomized, Single-blinded Study to Assess the Incidence of Wound Complications Following Total Knee and Hip Arthroplasty in Patients Treated With Two Different Types of Topical Skin Adhesive
This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.
Read the detailed description
The aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either Omnibond or Dermabond advanced topical skin adhesive. All patients undergoing a primary, elective TKA and THA at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications.
Secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.
- Conditions
- Osteoarthritis
- Being tested
- Omnibond Topical Skin Adhesive, Dermabond Advanced Topical Skin Adhesive
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnibond Topical Skin AdhesiveDevice
Application of Omnibond topical skin adhesive to close incision following surgery
Dermabond Advanced Topical Skin AdhesiveDevice
Application of Dermabond topical skin adhesive to close incision following surgery
| Study group | Role | What they receive |
|---|---|---|
| Omnibond topical skin adhesive | Active comparator | Not described Receives: Device: Omnibond Topical Skin Adhesive |
| Dermabond topical skin adhesive | Active comparator | Not described Receives: Device: Dermabond Advanced Topical Skin Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
All time wound complications
any occurrence of a wound-related complication following surgery
Measured: From surgery to 30 days post-op
Secondary outcomes (3)
Dry time
Time to dry (in seconds) between Omnibond vs Dermabond will be collected
Measured: From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand
User satisfaction with study treatment
Visual Analog Scale (VAS) will be used to ask users how satisfied they were with the product. The scale minimum value is 0 and maximum value is 100. The higher the score, the higher the user satisfaction with the study product
Measured: Up to 1 hour after study product application
Subject satisfaction with study treatment
Subjects will be asked at the time of first post-operative visit how satisfied they are with their study treatment using a Visual Analog Scale (VAS). The scale minimum value is 0 and maximum value is 100. The higher the score, the higher the patient satisfaction with the study product
Measured: Up to 14 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start25 Oct 2022
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: Temporarily halted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tiffany Morrison, MS, Study director, Center for Innovation and Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173519
- Sponsor's protocol ID
- Omnibond001
- Status last verified
- Feb 2024
- First submitted
- 29 Nov 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blinded Study to Assess the Incidence of Wound Complications Following Total Knee and Hip Arthroplasty in Patients Treated With Two Different Types of Topical Skin Adhesive
- ClinicalTrials.gov ID
- NCT05173519
- Acronym / sponsor ID
- Omnibond001
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily halted
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.
Detailed description
The aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either Omnibond or Dermabond advanced topical skin adhesive. All patients undergoing a primary, elective TKA and THA at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications.
Secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnibond topical skin adhesive | Active comparator | Device: Omnibond Topical Skin Adhesive |
| Dermabond topical skin adhesive | Active comparator | Device: Dermabond Advanced Topical Skin Adhesive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
- Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
- Subjects deemed able to understand and comply with study visit schedule and procedures
Key exclusion criteria (6 listed)
- Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery
- Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
- Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
- Subjects who have participated in this trial previously and who were withdrawn
- Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
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 |
|---|---|---|
| Omnibond Topical Skin AdhesiveApplication of Omnibond topical skin adhesive to close incision following surgery | Device | Omnibond topical skin adhesive |
| Dermabond Advanced Topical Skin AdhesiveApplication of Dermabond topical skin adhesive to close incision following surgery | Device | Dermabond topical skin adhesive |
Primary outcome
All time wound complications
Time frame: From surgery to 30 days post-op
any occurrence of a wound-related complication following surgery
3 secondary outcomes
Dry time
Time frame: From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand
User satisfaction with study treatment
Time frame: Up to 1 hour after study product application
Subject satisfaction with study treatment
Time frame: Up to 14 days following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Tiffany Morrison, MS study director
Center for Innovation and Research Organization
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnibond Topical Skin Adhesive and Dermabond Advanced Topical Skin Adhesive in people with Osteoarthritis, run by Center for Innovation and Research Organization at 4 sites 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 5 inclusion and 6 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: paused, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Results are not available in the source record.
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?
All time wound complications (time frame: From surgery to 30 days post-op). 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 7 Feb 2024.