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Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection
Sponsor: Mansoura University
Summary
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.
Official title: Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection : A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-07-01
Completion Date
2025-12-01
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
Topical Phenytoin-Loaded Hydrogel Dressing
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.
Conventional Postoperative Wound Care
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.
Locations (1)
Faculty of Medicine
Al Mansurah, Egypt