Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
研究概览
简要总结
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp). This study will use a "split-face" design, meaning one eyelid will be treated with the traditional surgery method and the other with Ziplyft, allowing a direct side-by-side comparison.
The objectives of the study are to compare Ziplyft treatment vs. traditional surgery by evaluating bruising, wound closure and incision, surgery case time, and subject/surgeon surveys.
详细描述
Blepharoplasty (upper eyelid surgery), is a procedure where excess upper eyelid skin that can interfere with peripheral vision is removed, resulting in improvement in peripheral vision and a more revitalized appearance. The amount of excess skin to be removed from each lid is marked symmetrically on both right and left sides just as it is in a standard blepharoplasty. The difference in this comparative study is that one side will be done using a blade, cautery to seal blood vessels, and sutures to close the incision which is how a standard blepharoplasty procedure is performed. On the other side, the exact same amount of tissue that was marked prior to the surgery will be removed. The fellow (second) side will use a clamp (Ziplyft) to compress the excess skin prior to removal so that there is no bleeding and therefore no need for cautery to seal blood vessels. The same amount of tissue will be removed on this second side; it will be all the marked tissue. As the clamp compresses the excess skin and seals it together, no suturing is required, and the incision can be closed with tissue adhesive which has been used for many years to close eyelid surgery incisions. Using the commercially available tissue adhesive eliminates the need for sutures to close the incision. Both right and left upper eyelids will have the same amount of tissue removed, similar to standard blepharoplasty surgery. Both sides will also have incisions; one will be closed with sutures, and the other will be closed with tissue adhesive. In summary, both right and left upper eyelids are getting a standard blepharoplasty procedure. One side is utilizing a clamp (Ziplyft) to eliminate bleeding and the need for sutures.
The surgeon will record case time for Ziplyft side and traditional blepharoplasty side. Post-op photos taken at day 3 and 7 will be used to assess ecchymosis (bruising) by a masked, independent professional (physician). Photos taken at 7 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by a masked, independent professional (physician). Participant- and surgeon-reported surveys will be used to evaluate satisfaction with the Ziplyft procedure and outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed written consent prior to participation in any study-related procedures.
- •Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
- •Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits.
- •Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
- •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.
排除标准
- •Subjects with a current Ptosis diagnosis
- •Subjects with a history of Graves' Disease
- •Subjects with Myasthenia Gravis
- •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).
- •Subjects that have had any previous surgery eyelid or eyebrow region.
- •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.
- •Active or recent (within 3 months) tobacco user
- •Allergy to adhesive glue
- •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.
- •Pregnant or nursing females.
结局指标
主要结局
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
时间窗: From the beginning of the surgical case until surgery has been completed
The surgeon will record the surgical case times for Ziplyft and standard blepharoplasty. For the Ziplyft side of the participant's face the surgical case time begins when the Ziplyft device touches the patient lid and ends 1 min after adhesive is applied as that is when it has cured. For the standard blepharoplasty side of the participant's face the surgical case time begins as the blade begins its first cut and ends once ointment has been applied.
Document post-operative ecchymosis with Ziplyft and standard blepharoplasty
时间窗: 3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)
Ecchymosis will be measured by post-operative photographs taken at day 3 and day 7. Photos will be rated on a 1-4 scale for ecchymosis by an independent masked observer (physician).
Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance.
时间窗: 9 days (± 3 days) to up to 2 months (± 1 month) post-operation
Photos taken at 9 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by an independent masked observer (physician).
Assess patient reported outcomes with Ziplyft versus standard blepharoplasty
时间窗: After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation
Patient satisfaction questionnaires regarding comfort, satisfaction, and healing experience will be administered to the participants on the day of surgery and at 2 months post operation.
Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty
时间窗: The day of surgery until 2 months (± 1 month) post-operation
A surgeon-reported questionnaire regarding the procedure efficiency, bleeding, and the use of cautery and suture will be administered following the surgical procedure. A second surgeon-reported questionnaire regarding the use of adhesive, bruising, swelling, scaring, and symmetry will be administered at 2-months post operation.
次要结局
未报告次要终点