OsteoarthritisNCT05166642
Bandgrip vs Traditional Sutures TJA
A study testing Bandgrip Micro-Anchor Wound Closure and Suture closure in people with Osteoarthritis, run by Center for Innovation and Research Organization at 1 site in United States.
Trial summary
Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Bandgrip Micro-Anchor Wound Closure and Suture closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to Jan 2024
- 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
- Subject is male or female greater than 18 years of age
- Scheduled to undergo primary total knee or total hip replacement
- Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule
Who cannot join
- Prior surgical incision or scar in close proximity of the proposed incision (<2 cm).
- Local skin conditions such as dermatitis, eczema, or psoriasis.
- Active or previous infection in the skin or the hip or knee to be operated.
- Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use
- Subject has a recent history of bleeding, coagulation and/or clotting disorders
- Subject has a known allergy to BandGrip material (polycarbonate)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedics
Philadelphia, Pennsylvania, 19107
About this study
Official title: Prospective, Randomized Clinical Trial Assessing Post-operative Wound Healing Complications Following Total Joint Arthroplasty When Using Bandgrip Incision Closure Compared to Standard Suture Closure
Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. Secure wound closure is an important step in preventing wound-related complications. The surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision.
Traditional incision closure following TJA includes sutures. These sutures are then removed in the office. BandGrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. It is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. The clear microanchors are 0.029 inches in height and do not puncture through the dermis. There is no need for medical removal as the patient can remove the bandage.
- Conditions
- Osteoarthritis
- Being tested
- Bandgrip Micro-Anchor Wound Closure, Suture closure
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bandgrip Micro-Anchor Wound ClosureDevice
This treatment group will utilize a suture closure technique for the deep dermal layers with Bandgrip being applied to the most superficial layer of the surgical incision
Suture closureDevice
This treatment gourd will utilize suture closure technique for all layers of the surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| Bandgrip Micro-Anchor Skin Closure | Active comparator | Not described Receives: Device: Bandgrip Micro-Anchor Wound Closure |
| Standard of Care wound closure | Active comparator | Standard Monocryl suture closure Receives: Device: Suture closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with wound healing complications
All wound-related complication following surgery
Measured: From time of surgery to 30 days post-op
Secondary outcomes (1)
Closure time of surgical wound
Time (in seconds) that it takes to close the incisional wound during surgery
Measured: Procedure (The time from the first skin pass with the suture needle until the time the last suture knot is tied will be recorded in seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start8 Mar 2021
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Temporary hold on recruitment
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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166642
- Sponsor's protocol ID
- Bandgrip001
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2021
- Last updated
- 11 Sep 2023
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Clinical Trial Assessing Post-operative Wound Healing Complications Following Total Joint Arthroplasty When Using Bandgrip Incision Closure Compared to Standard Suture Closure
- ClinicalTrials.gov ID
- NCT05166642
- Acronym / sponsor ID
- Bandgrip001
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary hold on recruitment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 22 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.
Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. Secure wound closure is an important step in preventing wound-related complications. The surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision.
Traditional incision closure following TJA includes sutures. These sutures are then removed in the office. BandGrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. It is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. The clear microanchors are 0.029 inches in height and do not puncture through the dermis. There is no need for medical removal as the patient can remove the bandage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bandgrip Micro-Anchor Skin Closure | Active comparator | Device: Bandgrip Micro-Anchor Wound Closure |
| Standard of Care wound closure | Active comparator | Device: Suture closureStandard Monocryl suture closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is male or female greater than 18 years of age
- Scheduled to undergo primary total knee or total hip replacement
- Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule
Key exclusion criteria (6 listed)
- Prior surgical incision or scar in close proximity of the proposed incision (<2 cm).
- Local skin conditions such as dermatitis, eczema, or psoriasis.
- Active or previous infection in the skin or the hip or knee to be operated.
- Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use
- Subject has a recent history of bleeding, coagulation and/or clotting disorders
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 |
|---|---|---|
| Bandgrip Micro-Anchor Wound ClosureThis treatment group will utilize a suture closure technique for the deep dermal layers with Bandgrip being applied to the most superficial layer of the surgical incision | Device | Bandgrip Micro-Anchor Skin Closure |
| Suture closureThis treatment gourd will utilize suture closure technique for all layers of the surgical incision. | Device | Standard of Care wound closure |
Primary outcome
Number of patients with wound healing complications
Time frame: From time of surgery to 30 days post-op
All wound-related complication following surgery
1 secondary outcome
Closure time of surgical wound
Time frame: Procedure (The time from the first skin pass with the suture needle until the time the last suture knot is tied will be recorded in seconds)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bandgrip Micro-Anchor Wound Closure and Suture closure in people with Osteoarthritis, run by Center for Innovation and Research Organization 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 3 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 11 Sep 2023. 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. 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?
Number of patients with wound healing complications (time frame: From time of 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 11 Sep 2023.