This randomized, parallel-arm clinical trial evaluated whether a topical phenytoin-loaded hydrogel dressing could improve postoperative wound healing in patients undergoing surgical resection and reconstruction for locally advanced oral squamous cell carcinoma. Twenty-four participants were randomized in a 1:1 ratio to conventional postoperative wound care alone or to the same conventional care plus topical phenytoin-loaded hydrogel. The primary outcome was postoperative wound healing assessed using the Pippi modification of the Landry Wound Healing Index. Secondary outcomes were postoperative complications, oral mucositis severity, postoperative pain, and length of hospital stay. Follow-up in the revised manuscript extends through six months after surgery.
Eligible participants had histopathologically confirmed, locally advanced oral squamous cell carcinoma and were scheduled for primary surgical resection with cervical neck dissection and reconstruction at the Oncology Center, Mansoura University. After enrollment, participants were randomly allocated to two groups. The control group received conventional postoperative wound care. The experimental group received the same conventional postoperative care plus a topical phenytoin-loaded poloxamer hydrogel applied twice daily for seven consecutive postoperative days, beginning immediately after surgery. Postoperative assessments included wound healing, complication severity, oral mucositis, pain, and hospital length of stay. The manuscript reports blinded postoperative outcome assessment, while patients and operating surgeons were not blinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
24
A poloxamer-based hydrogel containing phenytoin sodium 10% w/w in a 17.5% w/w Poloxamer 407 base. Applied topically twice daily for seven consecutive postoperative days, beginning immediately after surgery.
Extraoral Bacitracin-Neomycin ointment and 10% povidone-iodine, together with intraoral benzydamine hydrochloride oral spray and chlorhexidine gluconate mouthwash, administered as conventional postoperative wound care for one week.
Faculty of Medicine
Al Mansurah, Egypt
Postoperative Wound Healing Score
Wound healing and infection assessed using the Pippi modification of the Landry Wound Healing Index, scored from 0 (worst healing) to 6 (complete healing).
Time frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Postoperative Complications by Clavien-Dindo Classification
Postoperative complication severity assessed using the Clavien-Dindo classification
Time frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Oral Mucositis Severity by WHO Grading System
WHO oral mucositis grade: Grade 0 (no alteration), Grade I (pain and erythema), Grade II (erythema and ulcers), Grade III (ulcers requiring a liquid diet only), and Grade IV (unable to feed orally).
Time frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Postoperative Pain Intensity by Visual Analog Scale
Pain intensity measured on a 10-point Visual Analog Scale, where 0 corresponds to no pain and 10 to the worst possible pain.
Time frame: Postoperative day 2, day 5, week 1, month 3, and month 6, according to the Methods section
Length of Hospital Stay
Time frame: From hospital admission until discharge from the index surgical hospitalization, assessed up to 30 days.
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