Wound Healing After Endoscopic Sinus Surgery

NCT06070311 | Unknown

• 1 other identifier: endoscopic sinus surgery
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nasal Polyps; Chronic Sinusitis

Outcome Measures

Primary Outcomes (4)

• Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination.

  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. 1. Thin and easily removable crusts. 2. Moderate crust formation, requiring gentle removal. 3. 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.

  Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery

• Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding adhesions by Endoscopic examination.

  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. 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. 0 is the lowest score meaning no adhesions are formed while 3 is the highest score meaning severe adhesions are formed.

  Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery

• Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding granulation formation by Endoscopic examination

  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. 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. 0 is the lowest score meaning no granulation tissue is formed while 3 is the highest score meaning severe granulation tissue are formed.

  Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery

• Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding infection by Endoscopic examination.

  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. 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. 0 is the lowest score meaning there is no infection while 3 is the highest score meaning there is severe infection.

  Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery

Secondary Outcomes (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

Study Arms (2)

Thymoquinone (0.5%) and Olive oil ointment

ACTIVE COMPARATOR

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

No intervention

NO INTERVENTION

no intervention

Interventions

Thymoquinone (0.5%) and Olive oil ointment 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.

Also known as: thymoquinone and olive oil ointment

Thymoquinone (0.5%) and Olive oil ointment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unfit patient for surgery
• Pregnant and lactating women.
• Patients unwilling to participate.
• Patients who have unilateral disease.
• 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:
• Aspirin intolerance
• Asthma
• Mucociliary disorder
• Immunocompromised status.
• Patients with known allergic reactions to Thymoquinone or olive oil.
• Injury of the orbit with any tear in the periorbital area.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Alobid I, Anton E, Armengot M, Chao J, Colas C, del Cuvillo A, Davila I, Dordal MT, Escobar C, Fernandez-Parra B, Gras-Cabrerizo JR, Ibanez MD, Lluch M, Mateu V, Montoro J, Gili JR, Mullol J, Navarro AM, Pumarola F, Rondon C, Sanchez-Hernandez MC, Sarandeses A, Soler R, Valero AL; Rhinoconjunctivitis Committee; Spanish Society of Allergy and Clinical Immunology; Rhinology and Allergy Commission; Spanish Society of Otorhinolaryngology. SEAIC-SEORL. Consensus Document on Nasal Polyposis. POLINA Project. J Investig Allergol Clin Immunol. 2011;21 Suppl 1:1-58. No abstract available.

  PMID: 21714471 BACKGROUND

• Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.

  PMID: 21605125 BACKGROUND

• Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):565-72. doi: 10.1016/j.jaip.2016.04.012.

  PMID: 27393770 BACKGROUND

• Bachert C, Bhattacharyya N, Desrosiers M, Khan AH. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021 Feb 11;14:127-134. doi: 10.2147/JAA.S290424. eCollection 2021.

  PMID: 33603409 BACKGROUND

• Sari H, Karaketir S, Kumral TL, Akgun MF, Gurpinar B, Hanci D, Berkiten G, Uyar Y. The effect of platelet-rich fibrin (PRF) on wound healing, adhesion, and hemostasis after endoscopic sinus surgery in patients with nasal polyposis. Am J Otolaryngol. 2021 Sep-Oct;42(5):103010. doi: 10.1016/j.amjoto.2021.103010. Epub 2021 Mar 29.

  PMID: 33862565 BACKGROUND

• Soler ZM, Smith TL. Endoscopic sinus surgery checklist. Laryngoscope. 2012 Jan;122(1):137-9. doi: 10.1002/lary.22430. Epub 2011 Nov 17.

  PMID: 22095309 BACKGROUND

• Loftus CA, Soler ZM, Koochakzadeh S, Desiato VM, Yoo F, Nguyen SA, Schlosser RJ. Revision surgery rates in chronic rhinosinusitis with nasal polyps: meta-analysis of risk factors. Int Forum Allergy Rhinol. 2020 Feb;10(2):199-207. doi: 10.1002/alr.22487. Epub 2019 Nov 21.

  PMID: 31752051 BACKGROUND

• Testa D, Marcuccio G, Panin G, Bianco A, Tafuri D, Thyrion FZ, Nunziata M, Piombino P, Guerra G, Motta G. Nasal mucosa healing after endoscopic sinus surgery in chronic rhinosinusitis of elderly patients: role of topic alpha-tocopherol acetate. Aging Clin Exp Res. 2017 Feb;29(Suppl 1):191-195. doi: 10.1007/s40520-016-0647-x. Epub 2016 Nov 25.

  PMID: 27888473 BACKGROUND

• Darakhshan S, Bidmeshki Pour A, Hosseinzadeh Colagar A, Sisakhtnezhad S. Thymoquinone and its therapeutic potentials. Pharmacol Res. 2015 May-Jun;95-96:138-58. doi: 10.1016/j.phrs.2015.03.011. Epub 2015 Mar 28.

  PMID: 25829334 BACKGROUND

• Melguizo-Rodriguez L, de Luna-Bertos E, Ramos-Torrecillas J, Illescas-Montesa R, Costela-Ruiz VJ, Garcia-Martinez O. Potential Effects of Phenolic Compounds That Can Be Found in Olive Oil on Wound Healing. Foods. 2021 Jul 15;10(7):1642. doi: 10.3390/foods10071642.

  PMID: 34359512 BACKGROUND

• Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.

  PMID: 17903570 BACKGROUND

• Kennedy DW. Functional endoscopic sinus surgery. Technique. Arch Otolaryngol. 1985 Oct;111(10):643-9. doi: 10.1001/archotol.1985.00800120037003.

  PMID: 4038136 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Interventions

thymoquinone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Mostafa Osman, Professor

  Assiut University

  STUDY CHAIR

• Ahmed Gamal Sholkamy, Doctor

  Assiut University

  STUDY DIRECTOR

• Tarek Ashraf, Doctor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Mostafa Osman, Professor

CONTACT

01005267182; mohamed.ramadan@med.aun.edu.eg

Ahmed Gamal Sholkamy, Doctor

CONTACT

01147552060; ahmedshd1@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 6, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 6, 2023

Record last verified: 2023-10