Ziplyft™ for improved healing and satisfaction after blepharoplasty.

Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

This study will test whether Ziplyft™, a tissue adhesive, helps adults 35 and older having blepharoplasty heal with less bruising, good symmetry, and higher patient and surgeon satisfaction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: Osheru Inc. (Industry-sponsored)
• Locations: 5 sites (Miami, Florida and 4 other locations)
• Trial ID: NCT07144761 on ClinicalTrials.gov

What this trial studies

This interventional study uses Ziplyft™, a tissue adhesive, for wound closure in adults undergoing blepharoplasty and collects patient-reported outcomes and surgeon satisfaction. Key measured outcomes include bruising, symmetry, adhesive success for wound closure, and case time. Participants are adults aged 35 or older judged eligible for eyelid skin removal by the investigator and must attend planned preoperative and follow-up visits. The multi-site US study is conducted at participating ophthalmic centers in Florida, Minnesota, and Pennsylvania.

Who should consider this trial

Good fit: Adults aged 35 years or older with excess eyelid skin who are willing to return for required follow-up visits and, if of childbearing potential, have a negative pregnancy test and use acceptable contraception are ideal candidates.

Not a fit: Patients with a current ptosis diagnosis, those younger than 35, those who cannot attend follow-up visits, or who are pregnant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, Ziplyft could reduce bruising and case time while improving wound closure, cosmetic symmetry, and both patient and surgeon satisfaction after blepharoplasty.

How similar studies have performed: Tissue adhesives for skin closure have shown positive results in other settings, but specific clinical data on Ziplyft™ for blepharoplasty are limited and its use in this setting is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Provide signed written consent prior to participation in any study-related procedures.
2. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
3. Male or female adults, ≥ 35 years old at the Preoperative Visit
4. Willing to return for required follow-up visits.
5. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
6. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

Exclusion Criteria:

1. Subjects with a current Ptosis diagnosis
2. Subjects with a history of Graves' Disease
3. Subjects with Myasthenia Gravis
4. Subjects that in the opinion of the investigator are anatomically not conducive to using devices (e.g., heavy brow, severe hollowing of the upper eyelid, history of ocular or orbital trauma).
5. Subjects that have had any previous surgery eyelid or eyebrow region.
6. Use of anticoagulation therapy, including, but not limited to Aspirin, NSAIDS, Ibuprofen within 7 days and Xarelto, Warfarin, Enoxaparin, Plavix within 3 days prior to planned study procedure.
7. Active or recent (within 3 months) tobacco user
8. Allergy to adhesive glue
9. Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
10. Pregnant or nursing females.

Where this trial is running

Miami, Florida and 4 other locations

• Center for Excellence in Eye Care — Miami, Florida, United States (Recruiting)
• Vance Thompson Vision — Alexandria, Minnesota, United States (Recruiting)
• Eye Care Specialists — Kingston, Pennsylvania, United States (Recruiting)
• Vance Thompson Vision — Sioux Falls, South Dakota, United States (Recruiting)
• The Eye Centers of Racine and Kenosha, LTD — Kenosha, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Patricia Buehler, MD

Conditions Blepharoplasty