Spacer Graft Study
Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
Montefiore Medical Center
100 participants
Aug 1, 2021
INTERVENTIONAL
Conditions
Summary
To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by MRD2 (margin to reflex distance 2)
Eligibility
Inclusion Criteria1
- Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022
Exclusion Criteria3
- Younger than 18 years old
- Required concurrent surgeries (e.g., midface lift or full thickness skin graft) or required further surgeries on the operated eyelid within the 6 months postoperatively
- Patients with less than 1-month follow up will be excluded from all outcome analysis and those without postoperative 6-month data will be excluded from the postoperative month 6 MRD2 calculation
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Interventions
In this prospective, randomized clinical trial, patients who will already be undergoing lower eyelid retraction repair with a spacer graft will randomly be assigned via a randomization web-site to receive 1 of 3 spacer grafts: hard palate, autologous auricular cartilage, and porcine acellular dermal matrix (Enduragen). Both the patient and the surgeon will know which of the three possible grafts are being used.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04140734