Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach (RCT)

Post-operative Lower Eyelid Massage Versus Standard Care for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach in Traumatic Facial Fracture Repair, a Randomized Controlled Trial

Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up.

Study Overview

• Status: Completed
• Conditions: Zygomatic and Lefort II Fractures; Infraorbital Rim Fixation; Subciliary Approach Repair
• Intervention / Treatment: Procedure: lower eyelid massage

Detailed Description

• The massage technique was executed with the patient in a fully open-eyed state, maintaining an upward gaze. The lateral aspect of the distal phalanx of the index finger was employed, exerting pressure on the lower eyelid to bring its margin into contact with the upper eyelid margin for a duration of 10 seconds per repetition. This procedure comprises 10 repetitions per set, administered once hourly, spanning 10 hours daily. The massage instruction was provided either by the authors or plastic surgery residents.
• Facial fracture surgeries were conducted by experienced plastic surgeons and/or proficient 4th and 5th year plastic surgery residents at Chiang Mai University Hospital, utilizing the skin-muscle flap subciliary approach. All patients underwent surgery one week after injury to mitigate soft tissue swelling, which had subsided by that time.
• Consistent pre-operative, peri-operative, and post-operative care protocols were administered to both patient groups. Stitches at the subciliary incision site were extracted on post-operative day 5. Patients in the massage group were instructed to commence lower eyelid massage on the day when stitches were removed.
• The follow-up assessments were occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively. Evaluation criteria include the Grading of Lower Eyelid Scar Contracture (GLESCO). Additionally, grading of lower eyelid malpositioning, comfort scores, rate on a scale of 0-10, adapted from POSAS and Verbal Rating Scale, wound infection, dehiscence, eyelid comfort, and management related to the subciliary incision will be assessed and documented by the plastic surgeon (author) and plastic surgery resident.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients diagnosed with zygomatic and Lefort II fractures necessitating infraorbital rim fixation following motorcycle accidents, and presenting without external lower eyelid wounds.

Exclusion Criteria:

• Pre-existing lower eyelid retraction (from previous scar, neurogenic cause, myogenic cause or Graves' disease), incision alteration, communication barriers, inability to perform daily activities or lower eyelid massage (ECOG ≥ 2, PPS Adult Suandok ≤ 60), inability to attend follow-up visits, and patient refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage group; Patients in the experimental group received training and guidance from trained investigators regarding post-operative lower eyelid massage.	Procedure: lower eyelid massage; The massage technique was executed with the patient in a fully open-eyed state, maintaining an upward gaze. The lateral aspect of the distal phalanx of the index finger was employed, exerting pressure on the lower eyelid to bring its margin into contact with the upper eyelid margin for a duration of 10 seconds per repetition. This procedure comprised 10 repetitions per set, administered once hourly, spanning 10 hours daily. The massage instruction was provided either by the authors or plastic surgery residents.
No Intervention: Non-massage group; The control group receiving standard care without post-operative lower eyelid massage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grading of Lower Eyelid Scar Contracture (GLESCO)	An anatomical score adapted by the authors, which was not independently validated as it relies on consistent anatomy across patients. Patient in normal neutral gaze, examiner use a finger to push the patient's lower eyelid up to reach upper eyelid, evaluate the lower lid margin compare with cornea Grade 0: Can push lower eyelid up to 100% of cornea Grade 1: Can push lower eyelid up to 75% of cornea Grade 2: Can push lower eyelid up to 50% of cornea Grade 3: Can push lower eyelid up to 25% of cornea Grade 4: Can push lower eyelid less than 25% of cornea	The follow-up assessments occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively.
Grading of lower eyelid malpositioning	One of the complications encountered following lower-lid blepharoplasty, ranging in severity from mild lower-lid retraction to frank ectropion with marked lower-lid eversion. Patient in normal neutral gaze, examiner observe position and characteristic of lower eyelid. Grade 0: Normal eye position Grade 1: Lateral rounding of the eye Grade 2: Central sclera show involving limbus Grade 3: Mild eversion of lower lid with tear pooling in inferior cul-de-sac Grade 4: Frank outward eversion of lower lid with exposure of palpebral conjunctiva	The follow-up assessments occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively.
Comfort scores	Represent subjective clinical evaluations by patients, assessing the overall comfort of the eye, including factors like dryness and tightness of the eyelid, rated on a scale of 0-10, adapted from POSAS and Verbal Rating Scale	The follow-up assessments occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively.

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: scar contracture; subciliary incision; subciliary approach; lower eyelid massage; facial fracture; eyelid malposition; ectropion
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Fractures, Bone; Contracture
• Other Study ID Numbers: Department of surgery MED CMU

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