Incision, SurgicalNCT05251064
Orthopaedic Surgical Wound Closure Comparison Study
A study testing Suture, Clozex and Zipline in people with Incision, Surgical, run by University of Virginia at 1 site in United States.
Trial summary
This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incision, Surgical
- What is being tested?
- Suture, Clozex and Zipline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 20 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Patient scheduled to undergo elective orthopaedic surgical procedure with a minimum anticipated incision length of 3 cm.
- Willingness and ability to comply with scheduled visits and study procedures.
Who cannot join
- Revision Surgery
- Compromised wound healing (autoimmune disorder, chronic steroids, connective tissue disorder)
- Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantage, non-English speaking subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Randomized Controlled Trial of Wound Closure Techniques in Orthopaedic Surgery
This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
Read the detailed description
There are many surgical wound closure methods commonly used in practice today. These usually involve a combination of braided and monofilament sutures in the subcutaneous fascia and fat as well as the subcuticular layers of the skin. The methods chosen by surgeons vary widely even amongst partners at the same institution for many reasons, including training background and conflicting reports in the literature. In some cases, these closure techniques can be time consuming and associated with increased rates of poor cosmetic outcomes or complications. There have been new wound closure products to reach the market that have been designed (Zipline - Campbell, CA and Clozex - Wellesley, MA), claiming to increase the speed of closure and decrease the rate of complications. These products both utilize an adhesive backed film to adhere to the skin along with a proprietary method to enhance skin apposition to reduce tension during the healing process. There has been no randomized controlled trial to determine superiority of the above listed surgical closure methods compared to traditional methods.
Our study aims to compare a "traditional" wound closure using both braided and monofilament sutures to the newer wound closure systems. By determining which method provides superior results, we will improve patient outcomes and satisfaction. The study also aims to assess health care value by exploring the costs associated with each closure technique. In addition to material expenses associated with the traditional sutures, we seek to explore if there is a significant difference in the time required to perform each wound closure method. Every minute of anesthesia and operating room utilization is associated with costs borne by the patient and the health care system. By finding which closure method is the fastest and associated with the best outcome we can improve healthcare value.
These methods will be tested in a randomized controlled trial and will be analyzed with multivariate statistical analysis to examine statistical significance. Subjects will be randomized in a 1:1:1 fashion to sutures, Closex, or Zipline. Surgeons will complete a satisfaction questionnaire about the randomized method used for closure. Surgical subjects will complete a satisfaction questionnaire at two follow up visits that align with standard of care visits and will have the incision measured and examined. Our primary objective outcome measure will be an assessment of surgical scar dimensions. Our hypothesis is that the 3 study groups will have similar objective scar measurements but that the savings in time associated with the new wound closure methods will be significant.
- Conditions
- Incision, Surgical
- Being tested
- Suture, Clozex, Zipline
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureDevice
Standard suture wound closure device.
ClozexDevice
Interlaced adhesive wound closure device.
ZiplineDevice
Adhesive wound closure device using zip-tie like strips.
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | Standard suture wound closure Receives: Device: Suture |
| Adhesive wound closure device | Active comparator | Clozex wound closure device Receives: Device: Clozex |
| Adhesive wound closure device with zip ties | Active comparator | Zipline wound closure device Receives: Device: Zipline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stony Brook Scar Evaluation Scale
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Measured: 2-Weeks post-operative
Stony Brook Scar Evaluation Scale
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Measured: 3-Months post operative
Secondary outcomes (5)
Time to Close
The amount of time in seconds that it took to perform closure of the incision.
Measured: During the procedure, from beginning of wound closure to the completion of wound closure
Length of Incision
This is the measure in centimeters of the incision.
Measured: During the procedure, obtained after incision was closed.
Patient Satisfaction
Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.
Measured: 2 weeks post operative
Patient Satisfaction
Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.
Measured: 3 months post operative
Surgeon Satisfaction
Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower satisfaction.
Measured: Once (at application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start23 Apr 2019
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incision, SurgicalStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Miller, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251064
- Sponsor's protocol ID
- 21411
- Status last verified
- May 2025
- First submitted
- 21 Jan 2022
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual data will not be share. Group means will be shared.
Publications
Burke JF, MacLean IS, Smith JM, Hart JM, Miller MD. A Prospective, Randomized, Controlled Comparison of Adhesive Wound Closure Devices in an Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2022 Sep 23;6(9):e22.00179. doi: 10.5435/JAAOSGlobal-D-22-00179. eCollection 2022 Sep 1.
PubMed 36155955
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Wound Closure Techniques in Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT05251064
- Acronym / sponsor ID
- 21411
- Conditions
- Incision, Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
Detailed description
There are many surgical wound closure methods commonly used in practice today. These usually involve a combination of braided and monofilament sutures in the subcutaneous fascia and fat as well as the subcuticular layers of the skin. The methods chosen by surgeons vary widely even amongst partners at the same institution for many reasons, including training background and conflicting reports in the literature. In some cases, these closure techniques can be time consuming and associated with increased rates of poor cosmetic outcomes or complications. There have been new wound closure products to reach the market that have been designed (Zipline - Campbell, CA and Clozex - Wellesley, MA), claiming to increase the speed of closure and decrease the rate of complications. These products both utilize an adhesive backed film to adhere to the skin along with a proprietary method to enhance skin apposition to reduce tension during the healing process. There has been no randomized controlled trial to determine superiority of the above listed surgical closure methods compared to traditional methods.
Our study aims to compare a "traditional" wound closure using both braided and monofilament sutures to the newer wound closure systems. By determining which method provides superior results, we will improve patient outcomes and satisfaction. The study also aims to assess health care value by exploring the costs associated with each closure technique. In addition to material expenses associated with the traditional sutures, we seek to explore if there is a significant difference in the time required to perform each wound closure method. Every minute of anesthesia and operating room utilization is associated with costs borne by the patient and the health care system. By finding which closure method is the fastest and associated with the best outcome we can improve healthcare value.
These methods will be tested in a randomized controlled trial and will be analyzed with multivariate statistical analysis to examine statistical significance. Subjects will be randomized in a 1:1:1 fashion to sutures, Closex, or Zipline. Surgeons will complete a satisfaction questionnaire about the randomized method used for closure. Surgical subjects will complete a satisfaction questionnaire at two follow up visits that align with standard of care visits and will have the incision measured and examined. Our primary objective outcome measure will be an assessment of surgical scar dimensions. Our hypothesis is that the 3 study groups will have similar objective scar measurements but that the savings in time associated with the new wound closure methods will be significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Device: SutureStandard suture wound closure |
| Adhesive wound closure device | Active comparator | Device: ClozexClozex wound closure device |
| Adhesive wound closure device with zip ties | Active comparator | Device: ZiplineZipline wound closure device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Patient scheduled to undergo elective orthopaedic surgical procedure with a minimum anticipated incision length of 3 cm.
- Willingness and ability to comply with scheduled visits and study procedures.
Key exclusion criteria (3 listed)
- Revision Surgery
- Compromised wound healing (autoimmune disorder, chronic steroids, connective tissue disorder)
- Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantage, non-English speaking subjects.
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 |
|---|---|---|
| SutureStandard suture wound closure device. | Device | Suture |
| ClozexInterlaced adhesive wound closure device. | Device | Adhesive wound closure device |
| ZiplineAdhesive wound closure device using zip-tie like strips. | Device | Adhesive wound closure device with zip ties |
Primary outcome
Stony Brook Scar Evaluation Scale
Time frame: 2-Weeks post-operative
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Stony Brook Scar Evaluation Scale
Time frame: 3-Months post operative
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
5 secondary outcomes
Time to Close
Time frame: During the procedure, from beginning of wound closure to the completion of wound closure
Length of Incision
Time frame: During the procedure, obtained after incision was closed.
Patient Satisfaction
Time frame: 2 weeks post operative
Patient Satisfaction
Time frame: 3 months post operative
Surgeon Satisfaction
Time frame: Once (at application)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36155955Burke JF, MacLean IS, Smith JM, Hart JM, Miller MD. A Prospective, Randomized, Controlled Comparison of Adhesive Wound Closure Devices in an Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2022 Sep 23;6(9):e22.00179. doi: 10.5435/JAAOSGlobal-D-22-00179. eCollection 2022 Sep 1.
- Individual participant dataSharing planned: No. Individual data will not be share. Group means will be shared.
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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.
Mark Miller, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture, Clozex and Zipline in people with Incision, Surgical, run by University of Virginia 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 3 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 15 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2025). 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?
Stony Brook Scar Evaluation Scale (time frame: 2-Weeks post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251064, which also lists 1 linked publication.
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 15 Jun 2025.