Buccal Fat PadNCT07610993
Evaluating Salivary α - Amylase Levels Following Trigona Sp Honey Application To Post Palatoplasty Patients: A Pilot Randomized Clinical Study
A study testing Trigona sp honey with the buccal fat pad technique, framicetyn sulfate dressing with the buccal fat pad technique and Trigona sp. honey dressing without the buccal fat pad technique in people with Buccal Fat Pad and Cleft Palate, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Palatoplasty is a surgical procedure performed to restore palatal continuity and improve velopharyngeal function in patients with cleft palate. However, postoperative wound healing may influence scar formation, tissue quality, and maxillary growth. Read more about this study
- Who is it for?
- Ages 18 to 78 months
- Conditions the study is for
- Buccal Fat Pad, Cleft Palate, Honey
- What is being tested?
- Trigona sp honey with the buccal fat pad technique, framicetyn sulfate dressing with the buccal fat pad technique and Trigona sp. honey dressing without the buccal fat pad technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2024to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 78 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a diagnosis of unilateral cleft palate aged 18 months to 6,5 years.
- Patients undergoing palatoplasty surgery between June 2024 and June 2025 at Hasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar, Indonesia
- all participants parents agreed and signed an informed consent form to participate in examinations and evaluations through to the end of the study in accordance with research procedures
Who cannot join
- a history of systemic disease,
- allergies to honey ingredients,
- failure to follow the examination and evaluation until the end according to the research procedure
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hasanuddin University Dental Hospital
Makassar, South Sulawesi, 90245
About this study
Palatoplasty is a surgical procedure performed to restore palatal continuity and improve velopharyngeal function in patients with cleft palate. However, postoperative wound healing may influence scar formation, tissue quality, and maxillary growth. Various topical dressings have been used to reduce bacterial colonization and enhance tissue healing. Trigona sp. honey possesses antimicrobial, antioxidant, and anti-inflammatory properties that may promote wound healing, while framycetin sulfate is a commonly used aminoglycoside antibiotic dressing in palatoplasty. In addition, the buccal fat pad technique may improve tissue vascularization and epithelialization.
This pilot randomized clinical study aims to evaluate salivary α-amylase levels as a non-invasive biomarker of wound healing in post-palatoplasty patients receiving Trigona sp. honey or framycetin sulfate dressings, with or without buccal fat pad application. Salivary α-amylase levels will be measured preoperatively and on the fourth and seventh days postoperatively to assess inflammatory responses and healing dynamics following surgery.
Read the detailed description
Cleft palate is one of the most common craniofacial congenital anomalies requiring multidisciplinary management. Palatoplasty is performed to restore anatomical continuity of the palate, improve speech development, facilitate swallowing, and minimize psychosocial impairment. Nevertheless, postoperative wound healing may contribute to fibrosis, scar tissue formation, and impaired maxillary growth.
The wound healing process involves sequential phases including hemostasis, inflammation, proliferation, and remodeling. Excessive inflammation or delayed tissue repair may compromise postoperative outcomes. Therefore, identifying effective wound dressings and reliable biomarkers for monitoring healing is clinically important in oral and maxillofacial surgery.
Trigona sp. honey has demonstrated antibacterial, antioxidant, and anti-inflammatory effects attributed to its flavonoid and phenolic content. These properties may enhance tissue regeneration and reduce oxidative stress during healing. Framycetin sulfate dressing, an aminoglycoside antibiotic, is widely used to prevent bacterial colonization in surgical wounds. Furthermore, buccal fat pad application has been reported to improve vascularization, accelerate epithelialization, and reduce postoperative complications in cleft palate repair.
Salivary α-amylase is a non-invasive biomarker associated with sympathetic nervous system activation and inflammatory response. Increased α-amylase levels may reflect acute postoperative stress and inflammation, whereas decreasing levels may indicate progression toward tissue proliferation and healing. Saliva collection is simple, painless, and practical for pediatric patients, making it a promising diagnostic tool for postoperative monitoring.
This prospective pilot randomized clinical study with sample size estimation using G*Power version 3.1 determined a minimum of 24 participants patients diagnosed with unilateral cleft palate aged 18 months to 6,5 years who undergo palatoplasty using the two-flap push-back technique under general anesthesia between June 2024 and June 2025 at Hasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar, Indonesia. Participants will be randomly allocated into four intervention groups:
- Trigona sp. honey dressing with buccal fat pad technique
- Trigona sp. honey dressing without buccal fat pad technique
- Framycetin sulfate dressing with buccal fat pad technique
- Framycetin sulfate dressing without buccal fat pad technique
Salivary α-amylase levels will be measured preoperatively and on postoperatively and on the fourth and seventh days postoperatively using ELISA analysis. Clinical follow-up will evaluate wound healing, epithelialization, bleeding, infection, dehiscence, and adverse reactions.
The primary outcome is the change in salivary α-amylase levels among treatment groups over time. Secondary outcomes include clinical wound healing assessment and postoperative complication rates. The findings of this study are expected to support the development of non-invasive biomarkers for wound healing evaluation and explore Trigona sp. honey as a safe and economical alternative dressing material in post-palatoplasty management.
- Conditions
- Buccal Fat Pad, Cleft Palate, Honey, Salivary Alpha Amylase
- Being tested
- Trigona sp honey with the buccal fat pad technique, framicetyn sulfate dressing with the buccal fat pad technique, Trigona sp. honey dressing without the buccal fat pad technique, framicetyn sulfate dressing without the buccal fat pad technique
- Keywords
- buccal fat pad, cleft palate, framycetin sulfate, honey, salivary alpha-amylase
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigona sp honey with the buccal fat pad techniqueCombination product
Also called stingless bee
a species of stingless bee with the most significant composition of coconut pollen. This honey is one of the natural bioactive ingredients being researched and developed at Hasanuddin University. This honey has gone through the inspection process at the BPOM (Food and Drug Regulatory Agency) and is the standard for food and drug control in Indonesia. the amount of honey applied was ± 5 ml with a note: the condition of the honey absorbs all sides of the sterile gauze, then fixed with an obturator.
The buccal fat pad is a complex structure associated with important anatomical structures such as the facial nerve, parotid gland, and masticatory muscles. After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect
framicetyn sulfate dressing with the buccal fat pad techniqueCombination product
Also called sufratulle
The dressing commonly used in palatoplasty is framycetin sulfate (Darya-Varia Laboratory, Gunung Putri, Bogor, Indonesia) , an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis. framicetyn sulfate was applied according to the size of the obturator to be fixed.
The buccal fat pad is a complex structure associated with important anatomical structures such as the facial nerve, parotid gland, and masticatory muscles. After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect
Trigona sp. honey dressing without the buccal fat pad techniqueDietary supplement
Also called stingless bee
a species of stingless bee with the most significant composition of coconut pollen. This honey is one of the natural bioactive ingredients being researched and developed at Hasanuddin University. This honey has gone through the inspection process at the BPOM (Food and Drug Regulatory Agency) and is the standard for food and drug control in Indonesia. the amount of honey applied was ± 5 ml with a note: the condition of the honey absorbs all sides of the sterile gauze, then fixed with an obturator
framicetyn sulfate dressing without the buccal fat pad techniqueDrug
Also called sufratulle
The dressing commonly used in palatoplasty is framycetin sulfate (Darya-Varia Laboratory, Gunung Putri, Bogor, Indonesia) , an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis. framicetyn sulfate was applied according to the size of the obturator to be fixed.
| Study group | Role | What they receive |
|---|---|---|
| Trigona sp. honey dressing with the buccal fat pad technique | Experimental | Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing with the use of the buccal fat pad technique Receives: Combination Product: Trigona sp honey with the buccal fat pad technique |
| Trigona sp. honey dressing without the buccal fat pad technique | Experimental | Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing Receives: Dietary Supplement: Trigona sp. honey dressing without the buccal fat pad technique |
| framicetyn sulfate dressing with the buccal fat pad technique | Experimental | Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing with the use of the buccal fat pad technique Receives: Combination Product: framicetyn sulfate dressing with the buccal fat pad technique |
| framicetyn sulfate dressing without the buccal fat pad technique | Experimental | Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing Receives: Drug: framicetyn sulfate dressing without the buccal fat pad technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary α-Amylase Levels Following Palatoplasty
Salivary α-amylase levels will be measured using ELISA analysis to evaluate postoperative inflammatory response and wound healing following the application of (1) Trigona sp honey dressing with the buccal fat pad technique, (2) Trigona sp honey dressing without the buccal fat pad technique, (3) framycetin sulfate dressing with the buccal fat pad technique, (4) framycetin sulfate dressing with the buccal fat pad technique in post-palatoplasty patients.
Measured: Preoperative baseline, postoperative day 4, and postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal Fat PadStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Four arms factorials pilot randomized clinical study comparing -amylase level as a marker of wound healing following Trigona sp. honey and framycetin sulfate with or without buccal fat pad in post-palataloplasty patients
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nia Nurhaeni, Hasanuddin University
- Investigators
- abul Fauzi, DDS., MDS, Principal investigator, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610993
- Sponsor's protocol ID
- No. 074/KEPK FKG-RSGMP UH/EA/I
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared because the researchers have guaranteed the confidentiality of patient data
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Salivary α - Amylase Levels Following Trigona Sp Honey Application To Post Palatoplasty Patients: A Pilot Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07610993
- Acronym / sponsor ID
- No. 074/KEPK FKG-RSGMP UH/EA/I
- Conditions
- Buccal Fat Pad, Cleft Palate, Honey, Salivary Alpha Amylase
- Keywords
- buccal fat pad, cleft palate, framycetin sulfate, honey, salivary alpha-amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 28 May 2026 (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.
Palatoplasty is a surgical procedure performed to restore palatal continuity and improve velopharyngeal function in patients with cleft palate. However, postoperative wound healing may influence scar formation, tissue quality, and maxillary growth. Various topical dressings have been used to reduce bacterial colonization and enhance tissue healing. Trigona sp. honey possesses antimicrobial, antioxidant, and anti-inflammatory properties that may promote wound healing, while framycetin sulfate is a commonly used aminoglycoside antibiotic dressing in palatoplasty. In addition, the buccal fat pad technique may improve tissue vascularization and epithelialization.
This pilot randomized clinical study aims to evaluate salivary α-amylase levels as a non-invasive biomarker of wound healing in post-palatoplasty patients receiving Trigona sp. honey or framycetin sulfate dressings, with or without buccal fat pad application. Salivary α-amylase levels will be measured preoperatively and on the fourth and seventh days postoperatively to assess inflammatory responses and healing dynamics following surgery.
Detailed description
Cleft palate is one of the most common craniofacial congenital anomalies requiring multidisciplinary management. Palatoplasty is performed to restore anatomical continuity of the palate, improve speech development, facilitate swallowing, and minimize psychosocial impairment. Nevertheless, postoperative wound healing may contribute to fibrosis, scar tissue formation, and impaired maxillary growth.
The wound healing process involves sequential phases including hemostasis, inflammation, proliferation, and remodeling. Excessive inflammation or delayed tissue repair may compromise postoperative outcomes. Therefore, identifying effective wound dressings and reliable biomarkers for monitoring healing is clinically important in oral and maxillofacial surgery.
Trigona sp. honey has demonstrated antibacterial, antioxidant, and anti-inflammatory effects attributed to its flavonoid and phenolic content. These properties may enhance tissue regeneration and reduce oxidative stress during healing. Framycetin sulfate dressing, an aminoglycoside antibiotic, is widely used to prevent bacterial colonization in surgical wounds. Furthermore, buccal fat pad application has been reported to improve vascularization, accelerate epithelialization, and reduce postoperative complications in cleft palate repair.
Salivary α-amylase is a non-invasive biomarker associated with sympathetic nervous system activation and inflammatory response. Increased α-amylase levels may reflect acute postoperative stress and inflammation, whereas decreasing levels may indicate progression toward tissue proliferation and healing. Saliva collection is simple, painless, and practical for pediatric patients, making it a promising diagnostic tool for postoperative monitoring.
This prospective pilot randomized clinical study with sample size estimation using G*Power version 3.1 determined a minimum of 24 participants patients diagnosed with unilateral cleft palate aged 18 months to 6,5 years who undergo palatoplasty using the two-flap push-back technique under general anesthesia between June 2024 and June 2025 at Hasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar, Indonesia. Participants will be randomly allocated into four intervention groups:
- Trigona sp. honey dressing with buccal fat pad technique
- Trigona sp. honey dressing without buccal fat pad technique
- Framycetin sulfate dressing with buccal fat pad technique
- Framycetin sulfate dressing without buccal fat pad technique
Salivary α-amylase levels will be measured preoperatively and on postoperatively and on the fourth and seventh days postoperatively using ELISA analysis. Clinical follow-up will evaluate wound healing, epithelialization, bleeding, infection, dehiscence, and adverse reactions.
The primary outcome is the change in salivary α-amylase levels among treatment groups over time. Secondary outcomes include clinical wound healing assessment and postoperative complication rates. The findings of this study are expected to support the development of non-invasive biomarkers for wound healing evaluation and explore Trigona sp. honey as a safe and economical alternative dressing material in post-palatoplasty management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four arms factorials pilot randomized clinical study comparing -amylase level as a marker of wound healing following Trigona sp. honey and framycetin sulfate with or without buccal fat pad in post-palataloplasty patients
| Arm | Type | Receives |
|---|---|---|
| Trigona sp. honey dressing with the buccal fat pad technique | Experimental | Combination Product: Trigona sp honey with the buccal fat pad techniqueParticipants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing with the use of the buccal fat pad technique |
| Trigona sp. honey dressing without the buccal fat pad technique | Experimental | Dietary Supplement: Trigona sp. honey dressing without the buccal fat pad techniqueParticipants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing |
| framicetyn sulfate dressing with the buccal fat pad technique | Experimental | Combination Product: framicetyn sulfate dressing with the buccal fat pad techniqueParticipants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing with the use of the buccal fat pad technique |
| framicetyn sulfate dressing without the buccal fat pad technique | Experimental | Drug: framicetyn sulfate dressing without the buccal fat pad techniqueParticipants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing |
Who may qualify
- Ages
- 18 to 78 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a diagnosis of unilateral cleft palate aged 18 months to 6,5 years.
- Patients undergoing palatoplasty surgery between June 2024 and June 2025 at Hasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar, Indonesia
- all participants parents agreed and signed an informed consent form to participate in examinations and evaluations through to the end of the study in accordance with research procedures
Key exclusion criteria (3 listed)
- a history of systemic disease,
- allergies to honey ingredients,
- failure to follow the examination and evaluation until the end according to the research procedure
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 |
|---|---|---|
| Trigona sp honey with the buccal fat pad techniqueAlso: stingless beea species of stingless bee with the most significant composition of coconut pollen. This honey is one of the natural bioactive ingredients being researched and developed at Hasanuddin University. This honey has gone through the inspection process at the BPOM (Food and Drug Regulatory Agency) and is the standard for food and drug control in Indonesia. the amount of honey applied was ± 5 ml with a note: the condition of the honey absorbs all sides of the sterile gauze, then fixed with an obturator. The buccal fat pad is a complex structure associated with important anatomical structures such as the facial nerve, parotid gland, and masticatory muscles. After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect | Combination product | Trigona sp. honey dressing with the buccal fat pad technique |
| framicetyn sulfate dressing with the buccal fat pad techniqueAlso: sufratulleThe dressing commonly used in palatoplasty is framycetin sulfate (Darya-Varia Laboratory, Gunung Putri, Bogor, Indonesia) , an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis. framicetyn sulfate was applied according to the size of the obturator to be fixed. The buccal fat pad is a complex structure associated with important anatomical structures such as the facial nerve, parotid gland, and masticatory muscles. After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect | Combination product | framicetyn sulfate dressing with the buccal fat pad technique |
| Trigona sp. honey dressing without the buccal fat pad techniqueAlso: stingless beea species of stingless bee with the most significant composition of coconut pollen. This honey is one of the natural bioactive ingredients being researched and developed at Hasanuddin University. This honey has gone through the inspection process at the BPOM (Food and Drug Regulatory Agency) and is the standard for food and drug control in Indonesia. the amount of honey applied was ± 5 ml with a note: the condition of the honey absorbs all sides of the sterile gauze, then fixed with an obturator | Dietary supplement | Trigona sp. honey dressing without the buccal fat pad technique |
| framicetyn sulfate dressing without the buccal fat pad techniqueAlso: sufratulleThe dressing commonly used in palatoplasty is framycetin sulfate (Darya-Varia Laboratory, Gunung Putri, Bogor, Indonesia) , an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis. framicetyn sulfate was applied according to the size of the obturator to be fixed. | Drug | framicetyn sulfate dressing without the buccal fat pad technique |
Primary outcome
Change in Salivary α-Amylase Levels Following Palatoplasty
Time frame: Preoperative baseline, postoperative day 4, and postoperative day 7
Salivary α-amylase levels will be measured using ELISA analysis to evaluate postoperative inflammatory response and wound healing following the application of (1) Trigona sp honey dressing with the buccal fat pad technique, (2) Trigona sp honey dressing without the buccal fat pad technique, (3) framycetin sulfate dressing with the buccal fat pad technique, (4) framycetin sulfate dressing with the buccal fat pad technique in post-palatoplasty patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. The IPD will not be shared because the researchers have guaranteed the confidentiality of patient data
Related trials for Buccal Fat Pad
Recruiting
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
Atrophic Edentulous Maxilla, Zygomatic Implants
Recruiting
Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial
Soft Tissue Augmentation at Dental Implants
Recruiting
Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants
Zygomatic Implants, Atrophic Maxilla
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. This study is not recruiting at the moment.
abul Fauzi, DDS., MDS principal investigator
Department of Oral and Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigona sp honey with the buccal fat pad technique, framicetyn sulfate dressing with the buccal fat pad technique and Trigona sp. honey dressing without the buccal fat pad technique in people with Buccal Fat Pad and Cleft Palate, run by Hasanuddin University at 1 site in Indonesia.
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 3 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: finished, as of the sponsor's last update on 28 May 2026. 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 Indonesia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary α-Amylase Levels Following Palatoplasty (time frame: Preoperative baseline, postoperative day 4, and postoperative day 7). 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 28 May 2026.