Steri-Strip Tape Use in Unilateral Ectropion Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ectropion
• Intervention / Treatment: Other: Use Steri-Strip in post-surgery + standard care; Other: Standard care

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johana Benavides, MSc; Phone Number: 57 6015895377; Email: jbenavidescr@unisanitas.edu.co
• Study Contact Backup: Name: Johana Benavides, MSc

Study Locations

• Colombia
  • Bogotá, Colombia
    • Recruiting
    • Oftalmosanitas
    • Contact: Tatiana Gomez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Use Steri-Strip in post-surgery + standard care; Steri-strip will be maintained for 8 days postoperatively.
Other: 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.	Other: Standard care; Postoperative care recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical wound closure	This outcome will be evaluated using a slit lamp and defined as complete approximation of the wound edges. It will be recorded as a binary variable: Yes/No.	This will be assessed on postoperative day 8
Visual axis obstruction secondary to peripalpebral edema	This outcome will be evaluated using direct flashlight illumination. If a corneal light reflex is observed, it will indicate a clear visual axis.	It will be assessed on postoperative day 8.
Ocular surface symptoms	These symptoms are defined as the presence of ocular dryness, foreign body sensation, burning, or tearing. Each symptom will be recorded as present or absent. The presence of one or more of these symptoms will be interpreted as the occurrence of ocular surface symptoms.	This outcome will be assessed on postoperative days 8 and 30.

Collaborators and Investigators

• Sponsor: Claudia Aristizábal
• Investigators: Principal Investigator: Tatiana Gomez, MD, Unisanitas

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Ectropion
• Other Study ID Numbers: Steri-Strip Post-Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No