Wound Healing After Endoscopic Sinus Surgery

NCT ID: NCT06070311

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-10-31

Brief Summary

This study aims to determine the effect of Thymoquinone (0.5%) and olive oil ointment on Wound healing after Endoscopic sinus surgery.

Detailed Description

Endoscopic sinus surgery (ESS) has become a widely accepted procedure for medically refractory chronic rhino sinusitis and nasal polyps. Over 250,000 endoscopic sinus surgeries are performed yearly in the United States alone, however, postoperative complications and disease recurrence requiring revision surgery are reported in 14% to 24% of patients in long-term follow-up.

There is an increasing interest in interventions and therapies targeted at optimizing outcomes and preventing revision surgery which often depends on good wound healing and less adhesion formation.

The choice of appropriate post-surgical topical treatments is important for healing time and for preventing mucosal complications such as adhesions, crusting formation, and atrophy with secondary bacterial and fungal infections in this light this study aims to determine the effect of thymoquinone and olive oil ointment on wound healing after ESS.

Thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa seeds and most properties of Nigella sativa are mainly attributed to TQ. Several pharmacological actions and therapeutic potentials of TQ have been investigated including being antioxidant, anti-inflammatory, antihistaminic, antimicrobial, anti-allergic, anti-fibrotic, and anti-cancer.

Olive oil plays an important role in wound healing process due to its content of phenolic compounds accelerating wound healing through their anti-inflammatory, antioxidant, and antimicrobial properties and their stimulation of angiogenic activities required for granulation tissue formation and wound re-epithelialization.

This Double Blinded Randomized Prospective Comparative study will follow patients with nasal polyposis who are indicated for endoscopic sinus surgery at the Department of Otorhinolaryngology in Assiut University Hospital during the period from the 1st of October 2023 to the 31st of September 2025.

At baseline (before surgery), a full medical history, an otorhinolaryngological examination, and pre-operative screening will be performed to ensure eligibility for the study. The patients will be informed about the surgical procedures, the potential risks of the surgery, and the aim and methodology of the study.

(A) Preoperative:

Full history taking:

1. Personal History

2. History of Sino-nasal symptoms e.g., nasal obstruction, nasal discharge, headache, hyposmia, facial congestion, etc.

3. Other ENT symptoms

4. General symptoms e.g., asthma, allergy, etc.

5. Medical history e.g., steroids, antibiotics, anticholinergics, etc.

6. History of nasal surgery

7. SNOT 22 questionnaire: To assess preoperative severity of symptoms.

Full medical examination:

1. General examination

2. Full ENT examination

3. Nasal Endoscopy:

• To evaluate polyp size, site, extent, and consistency.

Investigations:

1. Routine preoperative investigations: CBC, prothrombin time and concentration

2. Radiological investigations: Multi-slice CT scan of the nose and paranasal sinuses axial and coronal cuts without contrast and each patient will be scored according to Lund-Mackay CT scoring.

Preparation of the Thymoquinone and Olive oil ointment:

Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows:

Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability.

(B) Intraoperative: All cases will be performed under general anaesthesia and the ESS procedure performed by the senior author is that defined by Kennedy.

Immediately after performing the ESS, Thymoquinone and olive oil Ointment will be applied to fill the ethmoidal and different sinuses cavities of one randomly chosen side of the nose, the selected side will be chosen randomly using the following online randomizer tool:

Randomizer | Random Name/Number Picker - AnnaBet.com Then nasal packing with nasal sponge will be done for both sides.

(C) Postoperative: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery. At these visits, an endoscopic inspection will be performed, and the patients will undergo debridement of the ethmoid cavities when necessary. In addition, endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides regarding adhesions, crust formation, granulation, infection and score each item using the scoring mentioned below.

Crust formation:

0: No crust formation observed.

1. Thin and easily removable crusts.

2. Moderate crust formation, requiring gentle removal.

3. Thick and adherent crusts, requiring careful and meticulous removal.

Adhesions:

0: No adhesions observed.

1. Mild adhesions, limited to small areas.

2. Moderate adhesions, affecting larger areas but without complete obstruction.

3. Severe adhesions, causing significant obstruction and impaired sinus drainage. 3.Granulation:

0: No granulations observed.

1. Mild granulation tissue, with minimal vascularity and minimal elevation.

2. Moderate granulation tissue, with moderate vascularity and noticeable elevation.

3. Severe granulation tissue, with marked vascularity and significant elevation. 4.Infection:

0: No signs or symptoms of infection observed.

1. Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity.

2. Moderate infection, mucopurulent discharge filling one sinus.

3. Severe infection, mucopurulent discharge filling more than one sinus.

Participants will take the SNOT-22 questionnaire after the operation at the follow up visits to evaluate sino nasal symptoms.

Conditions

Nasal Polyps; Chronic Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thymoquinone (0.5%) and Olive oil ointment

thymoquinone (0.5%) and olive oil ointment will be applied to fill the ethmoidal and different sinuses cavities of one randomly chosen side of the nose.

Group Type: ACTIVE_COMPARATOR

Thymoquinone (0.5%) and Olive oil ointment

Intervention Type: COMBINATION_PRODUCT

Preparation of the Thymoquinone and Olive oil ointment:

Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows:

Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability.

No intervention

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thymoquinone (0.5%) and Olive oil ointment

Preparation of the Thymoquinone and Olive oil ointment:

Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows:

Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

thymoquinone and olive oil ointment

Eligibility Criteria

Inclusion Criteria

• All patients who will be clinically diagnosed and radiologically confirmed cases with bilateral nasal polyposis indicated for Endoscopic sinus surgery.

Exclusion Criteria

1. Unfit patient for surgery

2. Pregnant and lactating women.

3. Patients unwilling to participate.

4. Patients who have unilateral disease.

5. Patients with a history of the following underlying medical conditions, which are associated with an increased rate of revision surgery, will be excluded from the study:

1. Aspirin intolerance

2. Asthma

3. Mucociliary disorder

4. Immunocompromised status.

6. Patients with known allergic reactions to Thymoquinone or olive oil.

7. Injury of the orbit with any tear in the periorbital area.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Ashraf Abdelhasib

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Mostafa Osman, Professor

Role: STUDY_CHAIR

Assiut University

Ahmed Gamal Sholkamy, Doctor

Role: STUDY_DIRECTOR

Assiut University

Tarek Ashraf, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Mohamed Mostafa Osman, Professor

Role: CONTACT

mohamed.ramadan@med.aun.edu.eg

01005267182

Ahmed Gamal Sholkamy, Doctor

Role: CONTACT

ahmedshd1@aun.edu.eg

01147552060

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Other Identifiers

endoscopic sinus surgery

Identifier Type: -

Identifier Source: org_study_id