Postoperative Wound Healing After Oral Cancer Surgery
Conditions
Brief 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.
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.
Interventions
DRUGTopical Phenytoin-Loaded Hydrogel Dressing
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.
DRUGConventional Postoperative Wound Care
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Patients and operating surgeons were not blinded. Postoperative clinical assessments were performed by investigators blinded to treatment allocation. The manuscript also states that statistical analyses were performed blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Wound Healing Score | Postoperative day 1, week 1, week 2, month 1, month 3, and month 6 | Wound healing and infection assessed using the Pippi modification of the Landry Wound Healing Index, scored from 0 (worst healing) to 6 (complete healing). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Mucositis Severity by WHO Grading System | Postoperative day 1, week 1, week 2, month 1, month 3, and month 6 | 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). |
| Postoperative Pain Intensity by Visual Analog Scale | Postoperative day 2, day 5, week 1, month 3, and month 6, according to the Methods section | Pain intensity measured on a 10-point Visual Analog Scale, where 0 corresponds to no pain and 10 to the worst possible pain. |
| Length of Hospital Stay | From hospital admission until discharge from the index surgical hospitalization, assessed up to 30 days. | — |
| Postoperative Complications by Clavien-Dindo Classification | Postoperative day 1, week 1, week 2, month 1, month 3, and month 6 | Postoperative complication severity assessed using the Clavien-Dindo classification |
Countries
Egypt
Outcome results
None listed