Pilot Study of Throat Packs Soaked in Gengigel Spray in Patients Undergoing Elective Surgery

NCT06947161 | Recruiting Early Phase 1

• 1 other identifier: 2024917-14215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Throat packs are commonly used in many surgical procedures involving the oral cavity and pharynx, primarily to prevent blood, saliva, and other debris from entering the lower respiratory tract, thereby maintaining a clear airway and reducing the risk of aspiration and respiratory complications. Traditionally, these packs are moistened with saline or used in a dry state, with the choice often depending on the surgeon's preference and specific surgical requirements. However, despite their widespread usage, the exploration of alternative substances to moisten throat packs, particularly those with additional therapeutic benefits, remains limited in medical research. This pilot study introduces Gengigel spray as an innovative alternative to saline for moistening throat packs. Gengigel, a hyaluronic acid (HA)-based product, is known for its healing properties and anti-inflammatory effects, which are beneficial in oral care. Gengigel provides a non-anesthetic approach that promotes tissue repair and reduces inflammation. This makes it particularly advantageous in the context of surgical procedures where reducing postoperative inflammation and promoting mucosal healing are crucial.

Conditions

Throat, Sore

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative sore throat.

  This will be assessed with Scoring System of Harding and McVey

  6 months

Secondary Outcomes (4)

• Severity of postoperative sore throat

  6 months

• Patient satisfaction

  6 months

• The presence of hoarseness of voice

  6 months

• The presence of cough

  6 months

Study Arms (2)

Saline soaked throat pack

EXPERIMENTAL

Throat pack used will be soaked with saline

Drug: Gengigel

Gengigel soaked throat pack

EXPERIMENTAL

Throat pack used will be soaked with gengigel

Drug: Gengigel

Interventions

Gengigel DRUG

Throat pack will be soaked with gengigel, and post operatively, will see if there is any presence of sore throat, severity of sore throat. 10 mlm of gengigel, in liquid form will be used to soak the throat pack. 30 patients will receive gengigel spray soaked throat pack, and control group will receive normal saline soaked throat pack

Gengigel soaked throat pack; Saline soaked throat pack

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Classified as ASA I-II, indicating a relatively low risk of complications from anesthesia
• Aged between 18 and 60 years, which represents a typical adult surgical population
• Both male and female patients, ensuring gender inclusivity and representation in the study findings

You may not qualify if:

• Existing sore throat prior to surgery, which could affect the baseline measurement of postoperative sore throat.
• Anticipation of a difficult airway, as these patients may require specialized intubation techniques that are not standardized across the study.
• More than two attempts at endotracheal tube (ETT) insertion, as multiple attempts could cause additional trauma and skew the study outcomes.
• Any trauma occurring during intubation, which could independently contribute to postoperative sore throat and other complications

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Sabreena Ismail

Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

sabreena ismail, MD

CONTACT

0136325555; dr.sabby90@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: rct

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 27, 2025
• Study Start: February 12, 2025
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)