Palate; WoundNCT06540690
Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
A study testing Palatal Wound in people with Palate; Wound and Wound Heal, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites in Brazil.
Trial summary
This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound, Wound Heal, Diabetes
- What is being tested?
- Palatal Wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Aug 2023to 6 Jan 2027
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);
- Patients with no morphological or pathological conditions on the palatine donor area;
- Patients who present indication for extraction and ridge preservation;
- The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;
- Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).
- Patients diagnosed with type 2 diabetes for more than 5 years who are using oral hypoglycemic agents or insulin supplementation, with HbA1c levels ranging from ≥ 6.1% to 8.5%.
- Non-diabetic patients with HbA1c levels below 6.1%.
Who cannot join
- Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
- Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Smokers patients;
- Pregnant or lactating patients;
- Patients who had had periodontal surgery on the study area;
- Patients who presents opportunistic oral lesions, mainly colonized the palate region;
- Use of dental prosthesis with palatal cover;
- Thin palatal mucosa (~2.0mm).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
College of Dentistry - São José dos Campos, Sao Paulo State University
São José dos Campos, São Paulo, 12245-310
Mauro P Santamaria, PhD, 55 12 3947 9055, mauro.santamaria@unesp.br
- Recruiting
Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe
São José dos Campos, São Paulo, 12245000
Ana Carolina F Bonafe, MS, +55 12 991711401, ana.bonafe@unesp.br
About this study
Official title: Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study
This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition.
Read the detailed description
The use of autogenous grafts from the palate for the reconstruction of gingival tissues is considered the gold standard for various periodontal and peri-implant reconstructions. Given the current aging of the population, it is essential to understand the cellular mechanisms responsible for the repair response in oral tissues and how they are affected by systemic diseases, such as diabetes mellitus (DM). The objectives of the present study, conducted through a controlled clinical trial, are to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients. This will be achieved through clinical analyses, patient-centered parameters, inflammatory biomarkers, and wound microbiome composition. To accomplish this, 50 patients will be divided into two groups: the Diabetic Group (D; n = 25), where diabetic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft, and the Control Group (GC; n = 25), where normoglycemic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft. The groups will be compared regarding clinical parameters, patient-centered measures, including remaining wound area, epithelialization, tissue thickness, immature wound area, tissue edema, early wound healing index, postoperative discomfort, quality of life, number of analgesics, and sensitivity of the operated area over a 3-month period. Furthermore, the wound biofilm will be described through microbiome analysis, and tissue, saliva, and wound exudate biomarkers will be characterized. Descriptive statistics will be expressed as mean ± standard deviation, clinical evaluations will be performed using repeated measures ANOVA, and patient-centered parameters will be assessed using the T-test. Finally, multiple linear regression and correlation tests will be employed.
- Conditions
- Palate; Wound, Wound Heal, Diabetes
- Being tested
- Palatal Wound
- Keywords
- Periodontology, Wound healing, Controlled Clinical Trial, Diabetes
- Medical subject headings
- Wounds and Injuries, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal WoundProcedure or surgery
With the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive 4.0 silk sutures.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic (D) | Active comparator | Palatal wound healing in diabetic patients Receives: Procedure: Palatal Wound |
| Control Group (CG) | Active comparator | Palatal wound healing in normoglycemic patients Receives: Procedure: Palatal Wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open Wound Area (OWA)
For this, standardized photographs will be taken. As a reference, a scale will be used to measure this area. These photographs will be exported to image software (Image J - National Institute of Health -NIH, Bethesda, USA), the area of the wound will be measured in square millimeters (Dias et al. 2015)
Measured: baseline, 7, 14, 21 days after surgery
Secondary outcomes (12)
Tissue Thickness (TT)
An endodontic spacer (Dentsply-Maillefer Instruments S.A. - Switzerland) with a rubber cursor will be placed in contact with the area until the palatal bone is reached, without pressing the tissue. The distance between the tip of the spacer and the cursor will be measured using a digital caliper (Dias et al., 2015).
Measured: baseline, 90 days after surgery
Epithelialization (E)
The wound will be colored with Shirley's solution and the epithelialized area will be quantified in the Image J. program. Then, with the total wound area, the % epithelialization will be calculated (Ozcelik et al., 2008).
Measured: baseline, 7, 14, 21, 30 e 90 days after surgery
Early wound healing index (EWHI)
According to Fickl et al. 2014 any modification in wound healing will be evaluated in five different degrees:
Complete wound closure with an absence of fibrin on the palate; Complete wound closure with the presence of a fibrin line on palate; Complete wound closure with the presence of a clot with fibrin on palate Incomplete wound closure with partial tissue necrosis on palate; Incomplete wound closure with total tissue necrosis on palate
Measured: 7 and 14 days after surgery
Tissue Edema (TE)
Tissue edema will be evaluated with the score: 1 = absent; 2 = slight; 3 = moderate; or 4 = severe (Sanz-Moliner et, 2013).
Measured: 7 days
Oral Health Impact Profile (OHIP)
Will be evaluated from a questionnaire with 14 questions based on 7 domains: functional limitations, physical pain, psychological discomfort, physical disability, psychological deficiency and social deficiency. The patient should respond to the questions within 14 days after the surgical procedure, performing a postoperative diary. For each question an answer must be given, represented in numbers, being: 0- Never; 1- Almost never; 2-Occasionally; 3-Quite frequent; 4-Very common; 5-I do not know (Tonetti MS et al. 2017)
Measured: 14 days
Number of analgesics
Number of analgesics used during 14 days after the procedure will be reported at the same postoperative diary (Tonetti et al. 2017).
Measured: 14 days
Patient Discomfort
By a visual analogic scale (VAS) of 100 mm to assess discomfort, patients will report pain diary during the 14 days after surgery. Scale extremes will be "no pain" to "extreme." (Tonetti et al. 2017).
Measured: 14 days
Qualitative somatosensory testing (QualST)
This analysis will evaluate somatosensorial profiles and pain conditions. For this, different stimulus will be performed on the wound and the following tests will be applied: (1) Touch stimulus will be applied with a swab by a single application for 1-2 sec in the wound; (2) Cold stimulus will be applied by a stainless steel dental spatula (kept cool in ice water, approximately 0 °C) with wound direct contact during 1-2 sec; (3) The pinprick stimulus will be performed with a periodontal probe with moderate force on the wound area for 1-2 s (Baad-Hansen et al, 2013) Patient will report hypersensitivity, hyposensitivity, or normosensitivity to touch, cold and painful stimulus.
Measured: 7, 14 days
Immunologic Analysis
With the goal to obtain baseline data for this parameter, crevicular gingival fluid from the gingival area next to the donor area will be collected previous surgery. An absorbent paper (PerioPaper, Oraflow, Plainview, NY, EUA) will be placed at wound edges without pressure during 40s. Collects with blood contamination will be discarded. Samples will be stored into a sterilized Eppendorf containing 100 μL Phosphate Buffer Saline 0.05% Tween 2 (PBS) at - 80 C. Growth factors (VEGF and EGF), chemokines (MIP-1α, MCP-1α), and cytokines (IL1β, IL6, IL10, TNFα) levels will be determinate by the multiplex assay. Moreover, MMP-2, MMP-9, TIMP-1, TIMP-2 will be measured by the same commercial human commercial kit.
Measured: baseline, 3, 7 days
Microbiome Analysis
The biofilm from the palatal region will be collected, and the samples will be stored in sterilized Eppendorf tubes containing 100 μL of Phosphate Buffer Saline 0.05% Tween 20 (PBS) at -80°C. Three laboratory steps will be performed for the evaluation of the palatal region's microbiome, which are as follows: (1) Bacterial DNA extraction; (2) PCR amplification of the 16S rRNA region; (3) Library preparation for sequencing - PCR targeting the V3-V4 region. Bacterial DNA extraction will be conducted using a specific kit (MasterPure Complete DNA and RNA Purification Kit - Biosearch Technologies), following the steps of cell lysis and DNA purification.
Measured: baseline, 7, 14, 21, 30 e 90 days after surgery
Tissue Analysis
To do so, the tissue sample collected during the surgical stage will be immediately immersed in 10% formaldehyde fixative for a period of 24 hours at room temperature. After the fixation period, the sample will be washed three times with a PBS solution at room temperature and then stored in 70% ethanol at 4°C. Using multiplexed immunofluorescence imaging technology (co-detection by indexing CODEX), a tissue atlas of the repair process will be generated for both healthy and diabetic patients. Biomarkers will be analyzed to determine the inflammatory profile, cell types, cell-cell contacts, and cellular neighborhoods, following the manufacturer's instructions (Black, 2021).
Measured: baseline
Saliva Analysis
After the collection of 5 ml of saliva, the sample will be centrifuged at 2800 g for 20 minutes at 4 ºC. The supernatant will be separated from the pellet, and to each 1 mL of saliva, 100 uL of a protease inhibitor solution (SIGMAFAST, Sigma, St. Louis, MO, USA) will be added. The following markers will be quantified through ELISA tests: (1) Histatin-1 (MBS2022124 H1, MyBioSource, San Diego, CA, USA), (2) Epidermal Growth Factor (EGF; KHG0061; Invitrogen, Waltham, MA, USA), and (3) Vascular Endothelial Growth Factor (VEGF-A; BMS277-2, Invitrogen, Waltham, MA, USA).
Measured: baseline, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Palate; WoundStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled clinical study, non-randomized, prospective, blinded, with a three-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540690
- Sponsor's protocol ID
- UEPJMF 14
- Status last verified
- Jan 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available at the end of the study after a direct request
Publications
Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
PubMed 25373688Kamalathevan P, Ooi PS, Loo YL. Silk-Based Biomaterials in Cutaneous Wound Healing: A Systematic Review. Adv Skin Wound Care. 2018 Dec;31(12):565-573. doi: 10.1097/01.ASW.0000546233.35130.a9.
PubMed 30475285Black S, Phillips D, Hickey JW, Kennedy-Darling J, Venkataraaman VG, Samusik N, Goltsev Y, Schurch CM, Nolan GP. CODEX multiplexed tissue imaging with DNA-conjugated antibodies. Nat Protoc. 2021 Aug;16(8):3802-3835. doi: 10.1038/s41596-021-00556-8. Epub 2021 Jul 2.
PubMed 34215862Fickl S, Fischer KR, Jockel-Schneider Y, Stappert CF, Schlagenhauf U, Kebschull M. Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study. Clin Oral Investig. 2014 Dec;18(9):2213-9. doi: 10.1007/s00784-014-1204-7. Epub 2014 Feb 23.
PubMed 24562700
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study
- ClinicalTrials.gov ID
- NCT06540690
- Acronym / sponsor ID
- UEPJMF 14
- Conditions
- Palate; Wound, Wound Heal, Diabetes
- Keywords
- Periodontology, Wound healing, Controlled Clinical Trial, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 6 Aug 2024 (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.
This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition.
Detailed description
The use of autogenous grafts from the palate for the reconstruction of gingival tissues is considered the gold standard for various periodontal and peri-implant reconstructions. Given the current aging of the population, it is essential to understand the cellular mechanisms responsible for the repair response in oral tissues and how they are affected by systemic diseases, such as diabetes mellitus (DM). The objectives of the present study, conducted through a controlled clinical trial, are to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients. This will be achieved through clinical analyses, patient-centered parameters, inflammatory biomarkers, and wound microbiome composition. To accomplish this, 50 patients will be divided into two groups: the Diabetic Group (D; n = 25), where diabetic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft, and the Control Group (GC; n = 25), where normoglycemic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft. The groups will be compared regarding clinical parameters, patient-centered measures, including remaining wound area, epithelialization, tissue thickness, immature wound area, tissue edema, early wound healing index, postoperative discomfort, quality of life, number of analgesics, and sensitivity of the operated area over a 3-month period. Furthermore, the wound biofilm will be described through microbiome analysis, and tissue, saliva, and wound exudate biomarkers will be characterized. Descriptive statistics will be expressed as mean ± standard deviation, clinical evaluations will be performed using repeated measures ANOVA, and patient-centered parameters will be assessed using the T-test. Finally, multiple linear regression and correlation tests will be employed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled clinical study, non-randomized, prospective, blinded, with a three-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Diabetic (D) | Active comparator | Procedure: Palatal WoundPalatal wound healing in diabetic patients |
| Control Group (CG) | Active comparator | Procedure: Palatal WoundPalatal wound healing in normoglycemic patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);
- Patients with no morphological or pathological conditions on the palatine donor area;
- Patients who present indication for extraction and ridge preservation;
- The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;
- Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).
Key exclusion criteria (8 listed)
- Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
- Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Smokers patients;
- Pregnant or lactating patients;
- Patients who had had periodontal surgery on the study area;
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 |
|---|---|---|
| Palatal WoundWith the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive 4.0 silk sutures. | Procedure or surgery | Control Group (CG), Diabetic (D) |
Primary outcome
Open Wound Area (OWA)
Time frame: baseline, 7, 14, 21 days after surgery
For this, standardized photographs will be taken. As a reference, a scale will be used to measure this area. These photographs will be exported to image software (Image J - National Institute of Health -NIH, Bethesda, USA), the area of the wound will be measured in square millimeters (Dias et al. 2015)
12 secondary outcomes
Tissue Thickness (TT)
Time frame: baseline, 90 days after surgery
Epithelialization (E)
Time frame: baseline, 7, 14, 21, 30 e 90 days after surgery
Early wound healing index (EWHI)
Time frame: 7 and 14 days after surgery
Tissue Edema (TE)
Time frame: 7 days
Oral Health Impact Profile (OHIP)
Time frame: 14 days
Number of analgesics
Time frame: 14 days
Patient Discomfort
Time frame: 14 days
Qualitative somatosensory testing (QualST)
Time frame: 7, 14 days
Immunologic Analysis
Time frame: baseline, 3, 7 days
Microbiome Analysis
Time frame: baseline, 7, 14, 21, 30 e 90 days after surgery
Tissue Analysis
Time frame: baseline
Saliva Analysis
Time frame: baseline, 7 days
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 6 Aug 2024.
- Background: PubMed 25373688Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
- Background: PubMed 30475285Kamalathevan P, Ooi PS, Loo YL. Silk-Based Biomaterials in Cutaneous Wound Healing: A Systematic Review. Adv Skin Wound Care. 2018 Dec;31(12):565-573. doi: 10.1097/01.ASW.0000546233.35130.a9.
- Background: PubMed 34215862Black S, Phillips D, Hickey JW, Kennedy-Darling J, Venkataraaman VG, Samusik N, Goltsev Y, Schurch CM, Nolan GP. CODEX multiplexed tissue imaging with DNA-conjugated antibodies. Nat Protoc. 2021 Aug;16(8):3802-3835. doi: 10.1038/s41596-021-00556-8. Epub 2021 Jul 2.
- Background: PubMed 24562700Fickl S, Fischer KR, Jockel-Schneider Y, Stappert CF, Schlagenhauf U, Kebschull M. Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study. Clin Oral Investig. 2014 Dec;18(9):2213-9. doi: 10.1007/s00784-014-1204-7. Epub 2014 Feb 23.
- Individual participant dataSharing planned: Yes. Data will be available at the end of the study after a direct request
Related trials for Palate; Wound
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Recruiting
Dynamics of Wound Healing in Patients With Obesity
Wound Healing
Active, not recruiting
Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing
Palatal Donor Site Wound Healing
Recruiting
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Mucosal Erosion, Gingival Recession
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.
College of Dentistry - São José dos Campos, Sao Paulo State University
São José dos Campos, Brazil
Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe
São José dos Campos, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal Wound in people with Palate; Wound and Wound Heal, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites in Brazil.
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 7 inclusion and 8 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Open Wound Area (OWA) (time frame: baseline, 7, 14, 21 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540690, which also lists 4 linked publications.
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 6 Aug 2024.