Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection : A Randomized Controlled Trial
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Early-stage disease.
Distant metastasis.
Poor performance status.
Uncontrolled diabetes mellitus.
Phenytoin allergy.
Collagen vascular diseases that could confound wound-healing outcomes.