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