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Wound Healing After Endoscopic Sinus Surgery

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06070311
Collaborator
(none)
50
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Thymoquinone (0.5%) and Olive oil ointment
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Thymoquinone and Olive Oil on Wound Healing After Endoscopic Sinus Surgery in Patients With Nasal Polyposis
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Combination Product: 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.
Other Names:
  • thymoquinone and olive oil ointment

    		•
    No Intervention: No intervention

    no intervention

    Outcome Measures

    Primary Outcome Measures

    1. Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination. [Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery]

      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. crust formation will be scored as following: 0: No crust formation observed. Thin and easily removable crusts. Moderate crust formation, requiring gentle removal. Thick and adherent crusts, requiring careful and meticulous removal. 0 is the lowest score meaning no crusts are formed while 3 is the highest score meaning severe crusts are formed.

    2. Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding adhesions by Endoscopic examination. [Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery]

      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. adhesions will be scored as following: 0: No adhesions observed. Mild adhesions, limited to small areas. Moderate adhesions, affecting larger areas but without complete obstruction. Severe adhesions, causing significant obstruction and impaired sinus drainage. 0 is the lowest score meaning no adhesions are formed while 3 is the highest score meaning severe adhesions are formed.

    3. Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding granulation formation by Endoscopic examination [Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery]

      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. Granulations will be scored as following: 0: No granulations observed. Mild granulation tissue, with minimal vascularity and minimal elevation. Moderate granulation tissue, with moderate vascularity and noticeable elevation. Severe granulation tissue, with marked vascularity and significant elevation. 0 is the lowest score meaning no granulation tissue is formed while 3 is the highest score meaning severe granulation tissue are formed.

    4. Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding infection by Endoscopic examination. [Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery]

      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. Infection will be scored as following: 0: No signs or symptoms of infection observed. Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity. Moderate infection, mucopurulent discharge filling one sinus. Severe infection, mucopurulent discharge filling more than one sinus. 0 is the lowest score meaning there is no infection while 3 is the highest score meaning there is severe infection.

    Secondary Outcome Measures

    1. Evaluation of symptoms of CRS and NP after Endoscopic Sinus Surgery using SNOT22 questionnaire. [Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery]

      Sinonasal Outcome Test (SNOT-22) Questionnaire will be taken by each participant before and after surgery. The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be). The overall score can theoretically range from 0 to 110, with higher scores reflecting more severe quality of life impairment as subjectively reported by the patient.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    6. Aspirin intolerance

    7. Asthma

    8. Mucociliary disorder

    9. Immunocompromised status.

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

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Mohamed Mostafa Osman, Professor, Assiut University
    • Study Director: Ahmed Gamal Sholkamy, Doctor, Assiut University
    • Principal Investigator: Tarek Ashraf, Doctor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tarek Ashraf Abdelhasib, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06070311
    Other Study ID Numbers:
    • endoscopic sinus surgery
    First Posted:
    Oct 6, 2023
    Last Update Posted:
    Oct 6, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sinusitis
    Nasal Polyps

    Study Results

    No Results Posted as of Oct 6, 2023