NCT06947161 Pilot Study of Throat Packs Soaked in Gengigel Spray in Patients Undergoing Elective Surgery
| NCT ID | NCT06947161 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Malaya |
| Condition | Throat, Sore |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2025-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-02-12 with a primary completion date of 2025-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Classified as ASA I-II, indicating a relatively low risk of complications from anesthesia 2. Aged between 18 and 60 years, which represents a typical adult surgical population 3. Both male and female patients, ensuring gender inclusivity and representation in the study findings Exclusion Criteria: 1. Existing sore throat prior to surgery, which could affect the baseline measurement of postoperative sore throat. 2. Anticipation of a difficult airway, as these patients may require specialized intubation techniques that are not standardized across the study. 3. More than two attempts at endotracheal tube (ETT) insertion, as multiple attempts could cause additional trauma and skew the study outcomes. 4. Any trauma occurring during intubation, which could independently contribute to postoperative sore throat and other complications
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06947161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Throat, Sore. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06947161 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06947161 currently recruiting?
Yes, NCT06947161 is actively recruiting participants. Contact the research team at dr.sabby90@gmail.com for enrollment information.
Where is the NCT06947161 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT06947161 clinical trial?
NCT06947161 is sponsored by University of Malaya. The trial plans to enroll 60 participants.