Steri-Strip Tape Use in Unilateral Ectropion Surgery

Claudia Aristizábal

Status: Not yet enrolling

Conditions: Ectropion

Treatments: Other: Standard care; Other: Use Steri-Strip in post-surgery + standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT06935227

Steri-Strip Post-Surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Use Steri-Strip in post-surgery + standard care

Active Comparator group

Description:

Within the first hour after unilateral ectropion surgery, Steri-Strip tapes (6 mm wide × 100 mm long, pack of 10 strips) will be applied to the operated eye. Six of these strips will be placed obliquely, hammock-style, 3 mm below the inferior orbital rim to direct the tension forces upward, using the lateral canthus of the operated eye as support. An additional strip will be placed horizontally, 2 mm above the orbital rim. The Steri-Strip tapes will be removed 8 days after surgery.

Treatment:

Other: Use Steri-Strip in post-surgery + standard care

Standard care

Other group

Description:

Standard care for ectropion surgery refers to the usual postoperative management provided without the use of additional supportive devices such as Steri-Strip tapes. It typically includes the application of ophthalmic antibiotic ointment, cold compresses, and instructions for eyelid hygiene.

Treatment:

Other: Standard care