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

C

Chiang Mai University

Status

Completed

Conditions

Infraorbital Rim Fixation
Subciliary Approach Repair
Zygomatic and Lefort II Fractures

Treatments

Procedure: lower eyelid massage

Study type

Interventional

Funder types

Other

Identifiers

NCT06311318
Department of surgery MED CMU

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 2 patient groups

Massage group
Experimental group
Description:
Patients in the experimental group received training and guidance from trained investigators regarding post-operative lower eyelid massage.
Treatment:
Procedure: lower eyelid massage
Non-massage group
No Intervention group
Description:
The control group receiving standard care without post-operative lower eyelid massage.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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