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Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection

NCT07801157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Postoperative Wound Healing After Oral Cancer Surgery

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801157 on ClinicalTrials.gov