Clinical trial · Interventional
Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection
Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection : A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Wound Healing After Oral Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Postoperative Wound Care | Drug | — | UNRESOLVED |
| Topical Phenytoin-Loaded Hydrogel Dressing | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Postoperative Wound Care
- description
- 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.
- interventionNames
- Drug: Conventional Postoperative Wound Care
- type
- EXPERIMENTAL
- label
- Phenytoin-Loaded Hydrogel + Conventional Care
- description
- Conventional postoperative wound care plus topical phenytoin-loaded hydrogel dressing applied twice daily for seven consecutive postoperative days, beginning immediately after surgery.
- interventionNames
- Drug: Topical Phenytoin-Loaded Hydrogel Dressing
- Drug: Conventional Postoperative Wound Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available