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Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate

NCT05191082 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-01-13

No results posted yet for this study

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.

Conditions

  • Wound Healing
  • Palate; Wound

Interventions

PROCEDURE

Palatal Wound

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.

DEVICE

Palatal Wound treated with Silk Fibroin Film

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.

DEVICE

Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film

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.

Sponsors & Collaborators

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    lead OTHER

Principal Investigators

  • Mauro P Santamaria · Sao Paulo States University - Brazil

  • Ana Carolina F Bonafe · Sao Paulo States University - Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-06-21
Completion
2022-07-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05191082 on ClinicalTrials.gov