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Recruiting NCT06935227

Steri-Strip Tape Use in Unilateral Ectropion Surgery

No phase Interventional Ectropion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use Steri-Strip in post-surgery + standard care, Standard care.
Who it may be relevant to
Registry conditions: Ectropion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Postoperative Outcomes of Steri-Strip Surgical Tape Use in Unilateral Ectropion Surgery: A Parallel-Controlled Clinical Trial

Overview

Currently, the incidence of involutional and chronic eyelid disorders, such as ectropion, has been increasing, as human life expectancy has risen worldwide (more than 600 million people are aged ≥ 60 years). Ectropion is a common eyelid malposition that causes visual morbidity. It is characterized by eversion of the eyelid margin and has multiple etiologies. Steri-Strip tapes have been used in some ophthalmologic procedures, such as blepharoplasties, where they help prevent infections by acting as a barrier method, are resistant enough to reduce the risk of wound dehiscence, simplify postoperative care, and allow for proper eyelid fissure closure. Their use has been recommended in patients with facial paralysis to prevent keratitis or exposure ulcers. However, current evidence is limited, as their use has only been documented in case series and letters to the editor. Therefore, a randomized controlled clinical trial is proposed to evaluate the postoperative outcomes of Steri-Strip tape use in unilateral ectropion surgery compared to standard postoperative management.

Detailed description

This study will compare the use of Steri-Strip tape in unilateral ectropion surgery with standard postoperative care to assess cosmetic and functional outcomes in the adult population. Participants will be followed up at 8 and 30 days after surgery.

Interventions

  • Other Use Steri-Strip in post-surgery + standard care
    Steri-strip will be maintained for 8 days postoperatively.
  • Other Standard care
    Postoperative care recommendations.

Primary outcome measures

  • Eyelid position [Time frame: Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.]
Secondary outcome measures (3)
  • Surgical wound closure [Time frame: This will be assessed on postoperative day 8]
  • Visual axis obstruction secondary to peripalpebral edema [Time frame: It will be assessed on postoperative day 8.]
  • Ocular surface symptoms [Time frame: This outcome will be assessed on postoperative days 8 and 30.]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.

Exclusion criteria

  • Underlying conditions associated with skin hyperlaxity, such as cutis laxa and Ehlers-Danlos syndrome.
  • Skin diseases that predispose to cicatricial ectropion, such as ichthyosis, scleroderma, and psoriasis.
  • Paralytic ectropion.
  • Current use of oral isotretinoin.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Colombia · 1 center
  • Oftalmosanitas — Bogotá

Identifiers

NCT: NCT06935227 · Steri-Strip Post-Surgery

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗