Steri-Strip Tape Use in Unilateral Ectropion Surgery

NCT06935227 | Recruiting DMC

• 1 other identifier: Steri-Strip Post-Surgery
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ectropion

Outcome Measures

Primary Outcomes (1)

• Eyelid position

  This outcome will be assessed using the margin reflex distance 2 (MRD2), which will be measured in millimeters (mm) from the central corneal light reflex (Hirschberg reflex) to the center of the lower eyelid margin. If this measurement exceeds 5 mm, it suggests that the tapes did not provide adequate support.

  Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.

Secondary Outcomes (3)

• Surgical wound closure

  This will be assessed on postoperative day 8

• Visual axis obstruction secondary to peripalpebral edema

  It will be assessed on postoperative day 8.

• Ocular surface symptoms

  This outcome will be assessed on postoperative days 8 and 30.

Study Arms (2)

Use Steri-Strip in post-surgery + standard care

ACTIVE COMPARATOR

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.

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

Standard care

OTHER

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.

Other: Standard care

Interventions

Use Steri-Strip in post-surgery + standard care OTHER

Steri-strip will be maintained for 8 days postoperatively.

Use Steri-Strip in post-surgery + standard care

Standard care OTHER

Postoperative care recommendations.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claudia Aristizábal: lead

Study Sites (1)

Oftalmosanitas

Bogotá, Colombia

RECRUITING

MeSH Terms

Conditions

Ectropion

Interventions

Postoperative Period; Standard of Care

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tatiana Gomez, MD

  Unisanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johana Benavides, MSc

CONTACT

57 6015895377; jbenavidescr@unisanitas.edu.co

Johana Benavides, MSc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)