Wound HealingNCT05191082
Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate
A study testing Palatal Wound, Palatal Wound treated with Silk Fibroin Film and Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film in people with Wound Healing and Palate; Wound, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The aim of the present study will be to manufacture and characterize silk fibroin membranes loaded or not with neurotensin and to evaluate clinical, patient-centered and immunological parameters the effect of using these membranes on open wounds on the human palate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing, Palate; Wound
- What is being tested?
- Palatal Wound, Palatal Wound treated with Silk Fibroin Film and Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2020to 1 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old, healthy systemically, with good oral hygiene, assessed by means of a plaque index and gingival index less than 25% (O'Leary et al., 1972)
- Patients with no morphological or pathological changes in the donor palatal region;
- Patients who have an indication for extraction and with an indication to preserve the socket for future implant installation;
- The tooth included in the study, as well as the adjacent teeth, must not have loss of periodontal insertion.
Who cannot join
- Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, diabetes, among others), who contraindicate the surgical procedure;
- Patients who use medications that interfere with wound healing;
- Pregnant or lactating patients;
- Patients who present opportunistic oral lesions, mainly colonizing the palate region;
- Smoking patients;
- Patients undergoing orthodontic treatment;
- Patients already submitted to periodontal surgery in the area of interest in the present study;
- Patients with a history of allergy to any type of material used in the present study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe
São José dos Campos, São Paulo, 12245000
About this study
Official title: Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate: Randomized Clinical Study
The aim of the present study will be to manufacture and characterize silk fibroin membranes loaded or not with neurotensin and to evaluate clinical, patient-centered and immunological parameters the effect of using these membranes on open wounds on the human palate.
Read the detailed description
Surgical procedures for the reconstruction of gingival and peri-Implant tissues with the purpose of restoring function and aesthetics are commonly used in the dental practice. The use of free gingival graft (FGG), despite being considered the gold standard, causes great morbidity and postoperative pain. Thus, in order to reduce these complications, some biomaterials have been explored to accelerate healing and bring greater comfort to the patient. The present study aims to: 1. manufacture silk fibroin membranes (SF), loaded or not with neurotensin (NT); 2. evaluate, clinically and immunologically, the effect of the membranes on open wounds at palate sites. After the manufacture of the membranes they will be characterized by visual aspect, thickness, mechanical properties, surface texture, water vapor permeability, enzymatic degradation and swelling. Posteriorly, sixty six (n = 66) patients requiring exodontia and ridge preservation for future implant placement will be randomly assigned into three groups: Control - Free Gingival Graft (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance; Group SF - Fibroin membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of the fibroin membrane at the palatal wound site; Group SF + NT - Free Gingival Graft + Neurotensin-loaded Fibroin Membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of neurotensin-loaded fibroin membrane at the palatal wound site. The repair of the palatine donor area will be evaluated by clinical parameters such as remaining wound area, tissue thickness, re-epithelialization and early-wound healing index at baseline, 7, 14, 21, 30, 45, and 90 days after the procedure; and patient-centered outcomes by post-operative discomfort, tissue edema and number of analgesic pills used for 14 days after the procedure. In addition, inflammatory cytokines and growth factors will be assessed using the palatal wound inflammatory exudate 3 and 7 days after surgery. For the descriptive statistics, the mean ± standard deviation will be used; Normality: Shapiro-Wilk test; Clinical trials: ANOVA for intra and inter group calculations + Tukey test for multiple comparisons when the Shapiro-Wilk p value ≥ 0.05. If p Shapiro-Wilk <0.05, will be analyzed using the Friedman test (intragroup) and Mann-Whitney tests (intergroup); Parameters centered on patients: T test.
- Conditions
- Wound Healing, Palate; Wound
- Being tested
- Palatal Wound, Palatal Wound treated with Silk Fibroin Film, Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film
- Keywords
- Periodontology, Wound healing, Silk fibroin, Randomized clinical trial, Drug Delivery System
- Medical subject headings
- Wounds and Injuries
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.
Palatal Wound treated with Silk Fibroin FilmDevice
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 a silk fibroin film and 4.0 silk sutures.
Palatal Wound treated with Neurotensin-loaded Silk Fibroin FilmDevice
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 a silk fibroin film loaded with neurotensin and 4.0 silk sutures.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | Sham comparator | The palatal wound area will not receive any treatment Receives: Procedure: Palatal Wound |
| Silk Fibroin Film - SF | Experimental | The palatal wound area will receive silk fibroin film as a dressing Receives: Procedure: Palatal Wound; Device: Palatal Wound treated with Silk Fibroin Film |
| Neurotensin-loaded Silk Fibroin Film - SF + NT | Experimental | The palatal wound area will receive a neurotensin-loaded silk fibroin film as a drug delivery system Receives: Procedure: Palatal Wound; Device: Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Remaining Wound Area (RWA)
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, 30, 45 and 90 days after surgery
Secondary outcomes (10)
Tissue Thickness
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, 45 and 90 days after the procedure
Scar and Tissue Colorimetry
The presence or absence of scar or keloid in the operated area will be analyzed. In addition, the tissue color similarity of regions adjacent to the operated area and postoperative images will be analyzed through photographs. The photographs will be exported to image software (Adobe Photoshop, München, Germany), using two areas, the wound and one adjacent. The comparison (ΔE) of the areas will be made using brightness parameters (L), red-green chroma scale and blue-yellow chroma scale (b) according to the following equation (Knösel et al., 2009): ΔE =[(L.wound - L.adjacent)2 + (a.wound - a.adjacent)2 + (b.wound - b.adjacent)2] 1/ 2
Measured: 7, 14, 21, 30, 45 and 90 postoperative days
Epithelialization
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, 3, 7, 14 and 30 days after the procedure
Early wound healing index
Any changes in wound healing will be evaluated, with five different degrees:
- Complete wound closure with absence of fibrin on the palate;
- Complete wound closure with the presence of a fibrin line on the palate;
- Complete wound closure with the presence of a fibrin clot on the palate;
- Incomplete wound closure with partial tissue necrosis on the palate;
- Incomplete wound closure with total tissue necrosis on the palate.
Measured: 7 and 14 days after surgery
Tissue edema
It will be evaluated with the score: 1 = absent; 2 = slight; 3 = moderate; or 4 = severe (Sanz-Moliner et al. 2013).
Measured: 7 days after the surgical procedure
Postoperative discomfort
Sensitivity will be measured by air spray for 5 s over the palatal region. After the air spray, patients will be required to use a 100 mm visual analog scale (VAS) to assess discomfort, where the extremes of the scale will be "none" and "extreme" to report the discomfort of this measure (Dias et al. 2015)
Measured: 7, 14, 21, 30, 45 and 90 days after the surgical procedure
Number of analgesics
Patients will be given a postoperative diary in which they will note their pain intensity on a visual analog scale (VAS) 100 mm and the number of painkillers used (Tonetti et. al 2017).
Measured: until 14 days after surgery
Immunologic Analysis - cytokines
The inflammatory exudate present in the palate open wound region will be collected. Samples will be obtained by placing strips of filter paper for 40 s (PerioPaper, Oraflow, New York, USA) in contact with the open wound. After the volume measurements (Periotron 8000, Oraflow, New York, USA), the strips will be placed in sterile tubes containing 300 ml of phosphate buffered saline (PBS) with 0.05% Tween-2 and stored immediately at -80 ° C. Strips contaminated with visible blood will be discarded. The following cytokines will be evaluated: Interleukin-1β (IL1β), Interleukin-4 (IL4), Interleukin-5 (IL5), Interleukin-6 (IL6), Interleukin-9 (IL9), Interleukin-10 (IL10), Interleukin-17A (IL17A), and tumor necrosis factor alpha (TNFα).
Measured: 3 and 7 days after surgery
Immunologic Analysis - growth factors
The inflammatory exudate present in the palate open wound region will be collected. Samples will be obtained by placing strips of filter paper for 40 s (PerioPaper, Oraflow, New York, USA) in contact with the open wound. After the volume measurements (Periotron 8000, Oraflow, New York, USA), the strips will be placed in sterile tubes containing 300 ml of phosphate buffered saline (PBS) with 0.05% Tween-2 and stored immediately at -80 ° C. Strips contaminated with visible blood will be discarded. The following growth factors will be evaluated: Epidermal growth factor (EGF), Transforming growth factor beta (TGF-β), Platelet-derived growth factor (PDGF), Fibroblast growth factors (FGF), and Vascular endothelial growth factor (VEGF).
Measured: 3 and 7 days after surgery
Immunologic Analysis - matrix metalloproteinases
The inflammatory exudate present in the palate open wound region will be collected. Samples will be obtained by placing strips of filter paper for 40 s (PerioPaper, Oraflow, New York, USA) in contact with the open wound. After the volume measurements (Periotron 8000, Oraflow, New York, USA), the strips will be placed in sterile tubes containing 300 ml of phosphate buffered saline (PBS) with 0.05% Tween-2 and stored immediately at -80 ° C. Strips contaminated with visible blood will be discarded. The following Matrix metalloproteinases will be evaluated: matrix metalloproteinase 9 (MMP-9), matrix metalloproteinase 2 (MMP-2), and Tissue inhibitors of metalloproteinases 1 and 2 (TIMP-1/TIMP-2).
Measured: 3 and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Sep 2020
- Primary completion21 Jun 2022 (estimated)
- Study completion1 Jul 2022 (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 Wound HealingStudies 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
- Parallel groups
- Model description
- Double-blind, parallel, superiority, randomized clinical trial with a 3 months of follow-up
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 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
- Investigators
- Mauro P Santamaria, Study director, Sao Paulo States University - BrazilAna Carolina F Bonafe, Principal investigator, Sao Paulo States University - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191082
- Sponsor's protocol ID
- UEPJMF 12
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kamalathevan 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 30475285Dias 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 25373688Zheng Z, Liu Y, Huang W, Mo Y, Lan Y, Guo R, Cheng B. Neurotensin-loaded PLGA/CNC composite nanofiber membranes accelerate diabetic wound healing. Artif Cells Nanomed Biotechnol. 2018;46(sup2):493-501. doi: 10.1080/21691401.2018.1460372. Epub 2018 Apr 13.
PubMed 29653498Pereira da Silva L, Miguel Neves B, Moura L, Cruz MT, Carvalho E. Neurotensin decreases the proinflammatory status of human skin fibroblasts and increases epidermal growth factor expression. Int J Inflam. 2014;2014:248240. doi: 10.1155/2014/248240. Epub 2014 Aug 11.
PubMed 25180119
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate: Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05191082
- Acronym / sponsor ID
- UEPJMF 12
- Conditions
- Wound Healing, Palate; Wound
- Keywords
- Periodontology, Wound healing, Silk fibroin, Randomized clinical trial, Drug Delivery System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 21 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 13 Jan 2022 (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.
The aim of the present study will be to manufacture and characterize silk fibroin membranes loaded or not with neurotensin and to evaluate clinical, patient-centered and immunological parameters the effect of using these membranes on open wounds on the human palate.
Detailed description
Surgical procedures for the reconstruction of gingival and peri-Implant tissues with the purpose of restoring function and aesthetics are commonly used in the dental practice. The use of free gingival graft (FGG), despite being considered the gold standard, causes great morbidity and postoperative pain. Thus, in order to reduce these complications, some biomaterials have been explored to accelerate healing and bring greater comfort to the patient. The present study aims to: 1. manufacture silk fibroin membranes (SF), loaded or not with neurotensin (NT); 2. evaluate, clinically and immunologically, the effect of the membranes on open wounds at palate sites. After the manufacture of the membranes they will be characterized by visual aspect, thickness, mechanical properties, surface texture, water vapor permeability, enzymatic degradation and swelling. Posteriorly, sixty six (n = 66) patients requiring exodontia and ridge preservation for future implant placement will be randomly assigned into three groups: Control - Free Gingival Graft (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance; Group SF - Fibroin membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of the fibroin membrane at the palatal wound site; Group SF + NT - Free Gingival Graft + Neurotensin-loaded Fibroin Membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of neurotensin-loaded fibroin membrane at the palatal wound site. The repair of the palatine donor area will be evaluated by clinical parameters such as remaining wound area, tissue thickness, re-epithelialization and early-wound healing index at baseline, 7, 14, 21, 30, 45, and 90 days after the procedure; and patient-centered outcomes by post-operative discomfort, tissue edema and number of analgesic pills used for 14 days after the procedure. In addition, inflammatory cytokines and growth factors will be assessed using the palatal wound inflammatory exudate 3 and 7 days after surgery. For the descriptive statistics, the mean ± standard deviation will be used; Normality: Shapiro-Wilk test; Clinical trials: ANOVA for intra and inter group calculations + Tukey test for multiple comparisons when the Shapiro-Wilk p value ≥ 0.05. If p Shapiro-Wilk <0.05, will be analyzed using the Friedman test (intragroup) and Mann-Whitney tests (intergroup); Parameters centered on patients: T test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, parallel, superiority, randomized clinical trial with a 3 months of follow-up
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Sham comparator | Procedure: Palatal WoundThe palatal wound area will not receive any treatment |
| Silk Fibroin Film - SF | Experimental | Procedure: Palatal Wound, Device: Palatal Wound treated with Silk Fibroin FilmThe palatal wound area will receive silk fibroin film as a dressing |
| Neurotensin-loaded Silk Fibroin Film - SF + NT | Experimental | Procedure: Palatal Wound, Device: Palatal Wound treated with Neurotensin-loaded Silk Fibroin FilmThe palatal wound area will receive a neurotensin-loaded silk fibroin film as a drug delivery system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 18 years old, healthy systemically, with good oral hygiene, assessed by means of a plaque index and gingival index less than 25% (O'Leary et al., 1972)
- Patients with no morphological or pathological changes in the donor palatal region;
- Patients who have an indication for extraction and with an indication to preserve the socket for future implant installation;
- The tooth included in the study, as well as the adjacent teeth, must not have loss of periodontal insertion.
Key exclusion criteria (8 listed)
- Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, diabetes, among others), who contraindicate the surgical procedure;
- Patients who use medications that interfere with wound healing;
- Pregnant or lactating patients;
- Patients who present opportunistic oral lesions, mainly colonizing the palate region;
- Smoking patients;
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), Neurotensin-loaded Silk Fibroin Film - SF + NT, Silk Fibroin Film - SF |
| Palatal Wound treated with Silk Fibroin FilmWith 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 a silk fibroin film and 4.0 silk sutures. | Device | Silk Fibroin Film - SF |
| Palatal Wound treated with Neurotensin-loaded Silk Fibroin FilmWith 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 a silk fibroin film loaded with neurotensin and 4.0 silk sutures. | Device | Neurotensin-loaded Silk Fibroin Film - SF + NT |
Primary outcome
Change in the Remaining Wound Area (RWA)
Time frame: baseline, 7, 14, 21, 30, 45 and 90 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)
10 secondary outcomes
Tissue Thickness
Time frame: baseline, 45 and 90 days after the procedure
Scar and Tissue Colorimetry
Time frame: 7, 14, 21, 30, 45 and 90 postoperative days
Epithelialization
Time frame: baseline, 3, 7, 14 and 30 days after the procedure
Early wound healing index
Time frame: 7 and 14 days after surgery
Tissue edema
Time frame: 7 days after the surgical procedure
Postoperative discomfort
Time frame: 7, 14, 21, 30, 45 and 90 days after the surgical procedure
Number of analgesics
Time frame: until 14 days after surgery
Immunologic Analysis - cytokines
Time frame: 3 and 7 days after surgery
Immunologic Analysis - growth factors
Time frame: 3 and 7 days after surgery
Immunologic Analysis - matrix metalloproteinases
Time frame: 3 and 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- 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 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 29653498Zheng Z, Liu Y, Huang W, Mo Y, Lan Y, Guo R, Cheng B. Neurotensin-loaded PLGA/CNC composite nanofiber membranes accelerate diabetic wound healing. Artif Cells Nanomed Biotechnol. 2018;46(sup2):493-501. doi: 10.1080/21691401.2018.1460372. Epub 2018 Apr 13.
- Background: PubMed 25180119Pereira da Silva L, Miguel Neves B, Moura L, Cruz MT, Carvalho E. Neurotensin decreases the proinflammatory status of human skin fibroblasts and increases epidermal growth factor expression. Int J Inflam. 2014;2014:248240. doi: 10.1155/2014/248240. Epub 2014 Aug 11.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mauro P Santamaria study director
Sao Paulo States University - Brazil
Ana Carolina F Bonafe principal investigator
Sao Paulo States University - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal Wound, Palatal Wound treated with Silk Fibroin Film and Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film in people with Wound Healing and Palate; Wound, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro P Santamaria (1239479062 ext. +55, mauro.santamaria@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Remaining Wound Area (RWA) (time frame: baseline, 7, 14, 21, 30, 45 and 90 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 NCT05191082, 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 13 Jan 2022.