Steri-Strip Tape Use in Unilateral Ectropion Surgery

NCT ID: NCT06935227

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Ectropion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Use Steri-Strip in post-surgery + standard care

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.

Group Type ACTIVE_COMPARATOR

Use Steri-Strip in post-surgery + standard care

Intervention Type OTHER

Steri-strip will be maintained for 8 days postoperatively.

Standard care

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.

Group Type OTHER

Standard care

Intervention Type OTHER

Postoperative care recommendations.

Interventions

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Use Steri-Strip in post-surgery + standard care

Steri-strip will be maintained for 8 days postoperatively.

Intervention Type OTHER

Standard care

Postoperative care recommendations.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Claudia Aristizábal

OTHER

Sponsor Role lead

Responsible Party

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Claudia Aristizábal

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tatiana Gomez, MD

Role: PRINCIPAL_INVESTIGATOR

Unisanitas

Locations

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Oftalmosanitas

Bogotá, , Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Johana Benavides, MSc

Role: CONTACT

57 6015895377

Johana Benavides, MSc

Role: CONTACT

Facility Contacts

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Tatiana Gomez, MD

Role: primary

Other Identifiers

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Steri-Strip Post-Surgery

Identifier Type: -

Identifier Source: org_study_id

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