Postoperative Wound Healing After Oral Cancer SurgeryNCT07801157
Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection
A study testing Topical Phenytoin-Loaded Hydrogel Dressing and Conventional Postoperative Wound Care in people with Postoperative Wound Healing After Oral Cancer Surgery, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Wound Healing After Oral Cancer Surgery
- What is being tested?
- Topical Phenytoin-Loaded Hydrogel Dressing and Conventional Postoperative Wound Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Topical Phenytoin-Loaded Hydrogel Dressing, Conventional Postoperative Wound Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Phenytoin-Loaded Hydrogel DressingDrug
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.
Conventional Postoperative Wound CareDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Postoperative Wound Care | Active comparator | 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. Receives: Drug: Conventional Postoperative Wound Care |
| Phenytoin-Loaded Hydrogel + Conventional Care | Experimental | Conventional postoperative wound care plus topical phenytoin-loaded hydrogel dressing applied twice daily for seven consecutive postoperative days, beginning immediately after surgery. Receives: Drug: Topical Phenytoin-Loaded Hydrogel Dressing; Drug: Conventional Postoperative Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Wound Healing Score
Wound healing and infection assessed using the Pippi modification of the Landry Wound Healing Index, scored from 0 (worst healing) to 6 (complete healing).
Measured: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Secondary outcomes (4)
Postoperative Complications by Clavien-Dindo Classification
Postoperative complication severity assessed using the Clavien-Dindo classification
Measured: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Oral Mucositis Severity by WHO Grading System
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).
Measured: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Postoperative Pain Intensity by Visual Analog Scale
Pain intensity measured on a 10-point Visual Analog Scale, where 0 corresponds to no pain and 10 to the worst possible pain.
Measured: Postoperative day 2, day 5, week 1, month 3, and month 6, according to the Methods section
Length of Hospital Stay
Measured: From hospital admission until discharge from the index surgical hospitalization, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jul 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound Healing After Oral Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801157
- Sponsor's protocol ID
- R.26.07.3804.R3
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Phenytoin-Loaded Hydrogel Dressing for Postoperative Wound Management After Oral Squamous Cell Carcinoma Resection : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07801157
- Acronym / sponsor ID
- R.26.07.3804.R3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Postoperative Wound Care | Active comparator | Drug: Conventional Postoperative Wound CareConventional 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. |
| Phenytoin-Loaded Hydrogel + Conventional Care | Experimental | Drug: Topical Phenytoin-Loaded Hydrogel Dressing, Drug: Conventional Postoperative Wound CareConventional postoperative wound care plus topical phenytoin-loaded hydrogel dressing applied twice daily for seven consecutive postoperative days, beginning immediately after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Early-stage disease.
- Distant metastasis.
- Poor performance status.
- Uncontrolled diabetes mellitus.
- Phenytoin allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Phenytoin-Loaded Hydrogel DressingA 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. | Drug | Phenytoin-Loaded Hydrogel + Conventional Care |
| Conventional Postoperative Wound CareExtraoral 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. | Drug | Conventional Postoperative Wound Care, Phenytoin-Loaded Hydrogel + Conventional Care |
Primary outcome
Postoperative Wound Healing Score
Time frame: 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).
4 secondary outcomes
Postoperative Complications by Clavien-Dindo Classification
Time frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Oral Mucositis Severity by WHO Grading System
Time frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6
Postoperative Pain Intensity by Visual Analog Scale
Time frame: Postoperative day 2, day 5, week 1, month 3, and month 6, according to the Methods section
Length of Hospital Stay
Time frame: From hospital admission until discharge from the index surgical hospitalization, assessed up to 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Phenytoin-Loaded Hydrogel Dressing and Conventional Postoperative Wound Care in people with Postoperative Wound Healing After Oral Cancer Surgery, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Wound Healing Score (time frame: Postoperative day 1, week 1, week 2, month 1, month 3, and month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.