Throat, SoreEarly Phase 1NCT06947161
Pilot Study of Throat Packs Soaked in Gengigel Spray in Patients Undergoing Elective Surgery
A Early Phase 1 study testing Gengigel in people with Throat, Sore, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Throat, Sore
- What is being tested?
- Gengigel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 12 Feb 2025to 12 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Sabreena Ismail
Kuala Lumpur, 50603
Rafidah Prof atan, MD, 0379494422 ext. 4422, rafidah.atan@ummc.edu.my
Sabreena Ismail, MD
About this study
Official title: The Pilot Study of Throat Packs Soaked in Gengigel Spray in Patients Undergoing Elective Surgery Under General Anaesthesia
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.
Read the detailed description
Using throat packs is a standard practice in surgeries involving the oral cavity, pharynx, and upper airway to prevent the aspiration of blood and other debris, which could lead to postoperative complications such as aspiration pneumonia. Traditionally, these throat packs are moistened with saline or left dry. However, this conventional approach has been associated with postoperative throat pain and discomfort, which are common and often distressing complications for patients undergoing surgery under general anesthesia. The discomfort caused by these packs can delay recovery, extend hospital stays, and negatively impact overall patient satisfaction with the surgical experience.
Gengigel presents a novel alternative with distinct advantages. Gengigel, which contains hyaluronic acid (HA), is recognized for its anti-inflammatory and healing properties, making it a promising candidate for improving postoperative outcomes when used in throat packs. Despite Gengigel's established use in other medical applications, such as wound care and oral health, there is currently no research exploring its effectiveness in moistening throat packs during surgical procedures. This represents a significant knowledge gap, as the combination of Gengigel's healing and anti-inflammatory effects could potentially address both pain and mucosal recovery.
Addressing this gap is crucial for advancing postoperative care, as current literature does not adequately explore the potential benefits or risks associated with using Gengigel in throat packs. Furthermore, there is a lack of data on patient outcomes, including the extent of pain relief, the speed of mucosal healing, potential complications, and overall patient satisfaction when Gengigel is utilized in this context. The absence of such data limits the ability of healthcare providers to make evidence-based decisions that could improve patient care.
To bridge this gap, this study proposes a randomized controlled trial (RCT) to compare the outcomes of using Gengigel-soaked throat packs versus traditional saline-soaked packs in patients undergoing surgery under general anesthesia. The study will systematically assess postoperative throat pain levels, evaluate the degree of mucosal healing, monitor for any adverse effects, and measure overall patient satisfaction. By conducting this comprehensive evaluation, the research aims to provide robust evidence that could guide the use of Gengigel in throat packs, potentially setting a new standard in postoperative care. Ultimately, the findings could lead to enhanced patient comfort, faster recovery times, and a higher quality of care for patients undergoing surgeries involving the oral cavity and pharynx.
- Conditions
- Throat, Sore
- Being tested
- Gengigel
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GengigelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Saline soaked throat pack | Experimental | Throat pack used will be soaked with saline Receives: Drug: Gengigel |
| Gengigel soaked throat pack | Experimental | Throat pack used will be soaked with gengigel Receives: Drug: Gengigel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat.
This will be assessed with Scoring System of Harding and McVey
Measured: 6 months
Secondary outcomes (4)
Severity of postoperative sore throat
This will be assessed with Scoring System of Harding and McVey
Measured: 6 months
Patient satisfaction
This will be assessed with a yes/no question regarding their overall satisfaction with the postoperative care.
Measured: 6 months
The presence of hoarseness of voice
This will be assessed with Scoring System of Harding and McVey
Measured: 6 months
The presence of cough
This will be assessed with Scoring System of Harding and McVey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start12 Feb 2025
- Primary completion12 Aug 2025 (estimated)
- Study completion12 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throat, SoreStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- rct
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SABREENA BINTI ISMAIL, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947161
- Sponsor's protocol ID
- 2024917-14215
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Study of Throat Packs Soaked in Gengigel Spray in Patients Undergoing Elective Surgery Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT06947161
- Acronym / sponsor ID
- 2024917-14215
- Conditions
- Throat, Sore
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 12 Aug 2025 (estimated)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Using throat packs is a standard practice in surgeries involving the oral cavity, pharynx, and upper airway to prevent the aspiration of blood and other debris, which could lead to postoperative complications such as aspiration pneumonia. Traditionally, these throat packs are moistened with saline or left dry. However, this conventional approach has been associated with postoperative throat pain and discomfort, which are common and often distressing complications for patients undergoing surgery under general anesthesia. The discomfort caused by these packs can delay recovery, extend hospital stays, and negatively impact overall patient satisfaction with the surgical experience.
Gengigel presents a novel alternative with distinct advantages. Gengigel, which contains hyaluronic acid (HA), is recognized for its anti-inflammatory and healing properties, making it a promising candidate for improving postoperative outcomes when used in throat packs. Despite Gengigel's established use in other medical applications, such as wound care and oral health, there is currently no research exploring its effectiveness in moistening throat packs during surgical procedures. This represents a significant knowledge gap, as the combination of Gengigel's healing and anti-inflammatory effects could potentially address both pain and mucosal recovery.
Addressing this gap is crucial for advancing postoperative care, as current literature does not adequately explore the potential benefits or risks associated with using Gengigel in throat packs. Furthermore, there is a lack of data on patient outcomes, including the extent of pain relief, the speed of mucosal healing, potential complications, and overall patient satisfaction when Gengigel is utilized in this context. The absence of such data limits the ability of healthcare providers to make evidence-based decisions that could improve patient care.
To bridge this gap, this study proposes a randomized controlled trial (RCT) to compare the outcomes of using Gengigel-soaked throat packs versus traditional saline-soaked packs in patients undergoing surgery under general anesthesia. The study will systematically assess postoperative throat pain levels, evaluate the degree of mucosal healing, monitor for any adverse effects, and measure overall patient satisfaction. By conducting this comprehensive evaluation, the research aims to provide robust evidence that could guide the use of Gengigel in throat packs, potentially setting a new standard in postoperative care. Ultimately, the findings could lead to enhanced patient comfort, faster recovery times, and a higher quality of care for patients undergoing surgeries involving the oral cavity and pharynx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- rct
| Arm | Type | Receives |
|---|---|---|
| Saline soaked throat pack | Experimental | Drug: GengigelThroat pack used will be soaked with saline |
| Gengigel soaked throat pack | Experimental | Drug: GengigelThroat pack used will be soaked with gengigel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GengigelThroat 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 | Drug | Gengigel soaked throat pack, Saline soaked throat pack |
Primary outcome
Incidence of postoperative sore throat.
Time frame: 6 months
This will be assessed with Scoring System of Harding and McVey
4 secondary outcomes
Severity of postoperative sore throat
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
The presence of hoarseness of voice
Time frame: 6 months
The presence of cough
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gengigel in people with Throat, Sore, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sabreena ismail, MD (0136325555, dr.sabby90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative sore throat. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.