An Early Phase 1 interventional study of Gengigel in Throat, Sore, sponsored by University of Malaya. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by University of Malaya · Early Phase 1, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 60 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Throat pack used will be soaked with saline
Drug: Gengigel
Throat pack used will be soaked with gengigel
Drug: Gengigel
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
Incidence of postoperative sore throat.
This will be assessed with Scoring System of Harding and McVey
Time frame: 6 months
Severity of postoperative sore throat
This will be assessed with Scoring System of Harding and McVey
Time frame: 6 months
Patient satisfaction
This will be assessed with a yes/no question regarding their overall satisfaction with the postoperative care.
Time frame: 6 months
The presence of hoarseness of voice
This will be assessed with Scoring System of Harding and McVey
Time frame: 6 months
The presence of cough
This will be assessed with Scoring System of Harding and McVey
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Aug 2025, 6 months after the start.
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Studies of the drug tested here: Hyaluronic Acid