Outpatient Treatment of Patients with abnormal scars.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5gvsgp
• Date of registration: 07/09/2011
• Primary sponsor: Universidade Presidente Antônio Carlos - Faculdade de Medicina de Juiz de Fora - Brazil
• Public title: Outpatient Treatment of Patients with abnormal scars.
• Scientific title: Outpatient Treatment of Keloids in patients treated in Juiz de Fora - MG. 2010.
• Date of first enrolment: 01/02/2010
• Target sample size: 43
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5gvsgp/
• Study design: Clinical trial, single-arm, nonrandomized, open.

Countries of recruitment

Brazil

Contacts

• Name: LUCAS DE ALMEIDA
• Affiliation: Universidade Presidente Antônio Carlos - Faculdade de Medicina de Juiz de Fora

• Name: Lucas de Almeida
• Affiliation: Universidade Presidente Antônio Carlos - Faculdade de Medicina de Juiz de Fora

Key inclusion & exclusion criteria

Inclusion criteria: We included all patients seen in primary routing path followed in an initial consultation and in their returns during treatment. We interviewed 62 patients with an interest in treating keloids as outpatients, but only 43 agreed to participate and signed an informed consent.
Exclusion criteria: The patients who refused treatment, who denied signing the consent form during the initial consultation were eliminated from the sample.

Age minimum: 1Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Measurement of the patient and their keloid formation in patients treated at the Surgery Clinic of the Institute of Clinical Specialist / PAM MARECHAL Juiz de Fora - MG.
A10.165.450.300.425

Intervention(s)

In order to analyze and identify factors related to keloid disease a questionnaire was developed and applied by researchers in one of the clinics Customer Service WFP MARSHAL. Along the interview was associated with treatment follow-up application without removal of 40 mg triamcinolone acetonide (TCN) injected into the lesion keloidal by the physician. Were administered (TCN) and monthly doses administered according to the size of the lesion. In therapeutic doses were calculated according to the measurement of the length x width of the initial keloids in adults: 1.2 cm ² TCN 40 mg (0.3 - 0.5 ml), 2 - 6 cm ² TCN 40 mg (0.5 - 1.0 ml) from 60 to 10 cm ² 40 mg (1.0 ml). The calculation of subsequent applications also comply with the assessment, however, there was need for change in starting dose in certain patients according to the evolution of the lesion. At the time the application was carried out with local antisepsis hydrated ethyl alcohol 63.3%, without anesthesia infiltrated the keloid with triamcinolone acetonide undiluted. Using 1 ml syringe and 29G needle (Insulin Syringe) for application, all materials purchased by the paciente.

Primary Outcome(s)

In the study, only objective data were used to measure the initial injury and the calculation of dose.Para evaluate the initial measures of lesion size in length and width was used parallel to the millimeter ruler medical injury in the initial consultation. The relief measures were evaluated according to the apex of the greater damage being also applied to lesions of irregular relief.

The therapy was based on the reference Ketchum, Robson and Masters (1971) Effects of Triamcinolone on Tendon on Healing and function: A Laboratory Study. For keloids and hypertrophic scars in various locations.

Was evaluated during the follow-up treatment the description of the lesions after treatment by subjective parameters. The aforementioned method was used to assess subjective symptoms, itching and pain. As such the patient completed the questionnaire during the follow-up

Secondary Outcome(s)

The analysis of relapse was made during the last visit, but by the time early in the sample will influence the subjective evaluation of the same evidence requiring a new approach to the patient after one year of treatment.

Secondary ID(s)

638/2010

Autorizado: Nov/2009