Anterior Cruciate Ligament ReconstructionNCT07217613
Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
A study testing silk fibroin-based incision dressing and cyanoacrylate-based closure system in people with Anterior Cruciate Ligament Reconstruction, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, blistering, and erythema between silk fibroin incision dressings and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- silk fibroin-based incision dressing and cyanoacrylate-based closure system
- 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
- 14 Oct 2025to 2 Jul 2026
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14 to 60 years
- Scheduled for primary or revision ACL reconstruction (ACLR)
- Able and willing to provide informed consent (≥18 years) or assent with parental/guardian permission (ages 14-17)
- Able and willing to comply with all study-related procedures and follow-up visits
Who cannot join
- Active dermatologic conditions at or near the surgical site (e.g., eczema, psoriasis, dermatitis, open wounds)
- Immunocompromised state (e.g., uncontrolled HIV, ongoing chemotherapy, chronic corticosteroid therapy)
- Known or suspected allergy or hypersensitivity to silk fibroin or cyanoacrylate adhesives
- Uncontrolled diabetes (defined as most recent HbA1c ≥ 8.0, if available; not measured for study purposes)
- Active systemic infection at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, blistering, and erythema between silk fibroin incision dressings and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction.
Read the detailed description
This is a prospective, randomized, parallel-group controlled trial conducted at a single academic medical center comparing a silk fibroin adhesive incision dressing (SYLKE) to a cyanoacrylate-based skin closure system (Dermabond or Prineo) in patients undergoing primary or revision anterior cruciate ligament reconstruction (ACLR). Participants are randomized 1:1 using a computer-generated allocation sequence stratified by operating surgeon. Wound closure is standardized across all participants prior to dressing application, ensuring that deep and dermal closure are identical between groups and independent of allocation.
The primary outcome is the incidence of early postoperative skin complications, including allergic contact dermatitis, blistering, erythema, and other incision-related complications, assessed at the first postoperative visit (7-14 days). Secondary outcomes include patient-reported comfort, itch, incision-site pain, satisfaction, and rehabilitation interference at approximately 30 days; dressing-related complications requiring clinical intervention through 30 days, captured via blinded electronic medical record review; and scar quality at a minimum of 3 months postoperatively using the Patient and Observer Scar Assessment Scale (POSAS v2.0), with the observer component scored by one unblinded clinical assessor and two fully blinded independent raters.
- Being tested
- silk fibroin-based incision dressing, cyanoacrylate-based closure system
- Keywords
- ACL reconstruction, silk fibroin, cyanoacrylate, sports medicine, SYLKE, wound dressing, allergic contact dermatitis
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silk fibroin-based incision dressingDevice
Also called SYLKE®, SYLKE Inc.
Applied sterile, hydrophobic, hypoallergenic dressing remains in place for 14-21 days, unless removal is clinically indicated (e.g., saturation, detachment, suspected allergic contact dermatitis, or at provider discretion).
cyanoacrylate-based closure systemDevice
Also called Dermabond®, Prineo®
Applied per standard NYU practice; dressing remains in place per routine protocol.
| Study group | Role | What they receive |
|---|---|---|
| Silk fibroin adhesive incision dressing | Experimental | Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR). Receives: Device: silk fibroin-based incision dressing |
| Standard closure dressing | Active comparator | Participants will receive the standard-of-care incision management currently used in ACL reconstruction at NYU Langone Orthopedic Surgery, consisting of cyanoacrylate-based closure systems (e.g., Dermabond® or Prineo®) as determined by the operating surgeon. Receives: Device: cyanoacrylate-based closure system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of postoperative skin complications
Incidence of allergic contact dermatitis, blistering, erythema, or other incision-related complications, assessed by the clinical team.
Measured: Follow-up 1 (7-14 days postoperatively)
Secondary outcomes (7)
Participant reported comfort rating (VAS)
Participants will complete a 0-10 VAS rating for incision site comfort.
Measured: Approximately 30 days postoperatively
Participant-reported itch rating (VAS)
Participants will complete a 0-10 VAS rating for itch.
Measured: approximately 30 days postoperatively
Rehabilitation Interference score
A 5-point Likert scale (none to extreme) will assess the perceived impact of incision-related discomfort on physical therapy participation and return to activity.
Measured: approximately 30 days postoperatively
Participant-reported incision-site pain rating (VAS)
Patients will complete a 0-10 VAS rating for incision site pain.
Measured: approximately 30 days postoperatively
Overall participant satisfaction rating (VAS)
Patients will complete a 0-10 VAS rating for satisfaction with the incision dressing.
Measured: approximately 30 days postoperatively
Participant and observer scar quality (POSAS v2.0)
POSAS v2.0 evaluates scar quality across pigmentation, pliability, thickness, and overall cosmetic outcome (6 items, 1-10 each; total 6-60, where 6 = normal skin and 60 = worst imaginable scar). The patient component is self-reported by the participant. The observer component is scored by one unblinded clinical assessor and two fully blinded independent raters; observer item-level scores are averaged across raters, with a pre-specified sensitivity analysis using only the two blinded raters.
Measured: 3 Months Post-Operatively
Dressing-related complications requiring intervention.
An independent, blinded review of 30-day wound-related events performed by a separate team member via EMR review.
Measured: approximately 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start14 Oct 2025
- Primary completion1 May 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J. Strauss, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217613
- Sponsor's protocol ID
- 25-01002
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a single-site, minimal-risk device study. Only aggregate results will be disseminated; individual datasets will not be shared. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: layne.estes@nyulangone.org or riley.mcconnell@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT07217613
- Acronym / sponsor ID
- 25-01002
- Keywords
- ACL reconstruction, silk fibroin, cyanoacrylate, sports medicine, SYLKE, wound dressing, allergic contact dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 16 Oct 2025 (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.
The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, blistering, and erythema between silk fibroin incision dressings and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction.
Detailed description
This is a prospective, randomized, parallel-group controlled trial conducted at a single academic medical center comparing a silk fibroin adhesive incision dressing (SYLKE) to a cyanoacrylate-based skin closure system (Dermabond or Prineo) in patients undergoing primary or revision anterior cruciate ligament reconstruction (ACLR). Participants are randomized 1:1 using a computer-generated allocation sequence stratified by operating surgeon. Wound closure is standardized across all participants prior to dressing application, ensuring that deep and dermal closure are identical between groups and independent of allocation.
The primary outcome is the incidence of early postoperative skin complications, including allergic contact dermatitis, blistering, erythema, and other incision-related complications, assessed at the first postoperative visit (7-14 days). Secondary outcomes include patient-reported comfort, itch, incision-site pain, satisfaction, and rehabilitation interference at approximately 30 days; dressing-related complications requiring clinical intervention through 30 days, captured via blinded electronic medical record review; and scar quality at a minimum of 3 months postoperatively using the Patient and Observer Scar Assessment Scale (POSAS v2.0), with the observer component scored by one unblinded clinical assessor and two fully blinded independent raters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silk fibroin adhesive incision dressing | Experimental | Device: silk fibroin-based incision dressingParticipants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR). |
| Standard closure dressing | Active comparator | Device: cyanoacrylate-based closure systemParticipants will receive the standard-of-care incision management currently used in ACL reconstruction at NYU Langone Orthopedic Surgery, consisting of cyanoacrylate-based closure systems (e.g., Dermabond® or Prineo®) as determined by the operating surgeon. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 14 to 60 years
- Scheduled for primary or revision ACL reconstruction (ACLR)
- Able and willing to provide informed consent (≥18 years) or assent with parental/guardian permission (ages 14-17)
- Able and willing to comply with all study-related procedures and follow-up visits
Key exclusion criteria (5 listed)
- Active dermatologic conditions at or near the surgical site (e.g., eczema, psoriasis, dermatitis, open wounds)
- Immunocompromised state (e.g., uncontrolled HIV, ongoing chemotherapy, chronic corticosteroid therapy)
- Known or suspected allergy or hypersensitivity to silk fibroin or cyanoacrylate adhesives
- Uncontrolled diabetes (defined as most recent HbA1c ≥ 8.0, if available; not measured for study purposes)
- Active systemic infection at the time of enrollment
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 |
|---|---|---|
| silk fibroin-based incision dressingAlso: SYLKE®, SYLKE Inc.Applied sterile, hydrophobic, hypoallergenic dressing remains in place for 14-21 days, unless removal is clinically indicated (e.g., saturation, detachment, suspected allergic contact dermatitis, or at provider discretion). | Device | Silk fibroin adhesive incision dressing |
| cyanoacrylate-based closure systemAlso: Dermabond®, Prineo®Applied per standard NYU practice; dressing remains in place per routine protocol. | Device | Standard closure dressing |
Primary outcome
Incidence rate of postoperative skin complications
Time frame: Follow-up 1 (7-14 days postoperatively)
Incidence of allergic contact dermatitis, blistering, erythema, or other incision-related complications, assessed by the clinical team.
7 secondary outcomes
Participant reported comfort rating (VAS)
Time frame: Approximately 30 days postoperatively
Participant-reported itch rating (VAS)
Time frame: approximately 30 days postoperatively
Rehabilitation Interference score
Time frame: approximately 30 days postoperatively
Participant-reported incision-site pain rating (VAS)
Time frame: approximately 30 days postoperatively
Overall participant satisfaction rating (VAS)
Time frame: approximately 30 days postoperatively
Participant and observer scar quality (POSAS v2.0)
Time frame: 3 Months Post-Operatively
Dressing-related complications requiring intervention.
Time frame: approximately 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. This is a single-site, minimal-risk device study. Only aggregate results will be disseminated; individual datasets will not be shared. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: layne.estes@nyulangone.org or riley.mcconnell@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Eric J. Strauss, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silk fibroin-based incision dressing and cyanoacrylate-based closure system in people with Anterior Cruciate Ligament Reconstruction, run by NYU Langone Health 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 4 inclusion and 5 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 17 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of postoperative skin complications (time frame: Follow-up 1 (7-14 days postoperatively)). 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 17 Aug 2026.