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Completed NCT07801157

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

Conditions: Postoperative Wound Healing After Oral Cancer Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Mansoura University

Location: Faculty of Medicine Al Mansurah

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07801157). StuddyBuddy aggregates publicly available trial information.