Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection
September 2, 2026 updated by: Mansoura University
Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection : A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Al Mansurah, Egypt
- Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with locally advanced oral squamous cell carcinoma eligible for oncologic resection and reconstruction . Participants were aged 18-80 years, they had no evidence of distant metastasis they demonstrated good general health, defined as a Karnofsky Performance Status >70 or ASA physical status I-III
Exclusion Criteria:
Early-stage disease.
Distant metastasis.
Poor performance status.
Uncontrolled diabetes mellitus.
Phenytoin allergy.
Collagen vascular diseases that could confound wound-healing outcomes.
- phenytoin allergy
- collagen vascular diseases that could confound wound healing outcomes.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Postoperative Wound Care
Conventional postoperative wound care for one week beginning on the day of surgery.
Extraoral care consisted of Bacitracin-Neomycin ointment and 10% povidone-iodine.
Intraoral care consisted of benzydamine hydrochloride oral spray and chlorhexidine gluconate mouthwash.
Application frequencies for these standard-care products are not stated in the manuscript.
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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.
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Experimental: Phenytoin-Loaded Hydrogel + Conventional Care
Conventional postoperative wound care plus topical phenytoin-loaded hydrogel dressing applied twice daily for seven consecutive postoperative days, beginning immediately after surgery.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Wound Healing Score
Time Frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
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Wound healing and infection assessed using the Pippi modification of the Landry Wound Healing Index, scored from 0 (worst healing) to 6 (complete healing).
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Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Complications by Clavien-Dindo Classification
Time Frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
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Postoperative complication severity assessed using the Clavien-Dindo classification
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Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
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Oral Mucositis Severity by WHO Grading System
Time Frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
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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).
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Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
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Postoperative Pain Intensity by Visual Analog Scale
Time Frame: Postoperative day 2, day 5, week 1, month 3, and month 6, according to the Methods section
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Pain intensity measured on a 10-point Visual Analog Scale, where 0 corresponds to no pain and 10 to the worst possible pain.
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Postoperative day 2, day 5, week 1, month 3, and month 6, according to the Methods section
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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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From hospital admission until discharge from the index surgical hospitalization, assessed up to 30 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
August 27, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- R.26.07.3804.R3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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