Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06311318
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT
Brief Summary:
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: