Effect of Photobiomodulation in a Partial Thickness Autogenous Skin Graft Donor Area

NCT ID: NCT03699852

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2020-01-10

Brief Summary

This is a clinical study with a controlled series of cases, whose objectives were: to evaluate the effects of FBM, using LED, on the repair process of the skin graft donor area treated with Membracel® and LED versus Membracel ®; to evaluate the evolution of the quality of the aspects of the skin donor area, through the score obtained by the modified Bates-Jensen Scale; the intensity of the pain reported by the participants; the size of the wound area until the 7th postoperative (PO) period and the time for re-epithelialization of the donor area. Data collection was performed at the Burn Unit of the General Hospital "Dr. José Pangella", from Vila Penteado, São Paulo, Brazil. The sample consisted of 21 participants and 25 donor areas, 13 of which were from the control group, which received only conventional treatment (Membracel®) and 12 from the experimental group: Membracel® and LED. Data collection instruments were used: medical records of the participants, anamnesis and physical examination, the scales: pain (Visual Analogic Scale - VAS) and Bates-Jensen to accompany the re-epithelialization process and the measurement of donor skin areas in the postoperative period. Quantitative variables were represented by the mean, standard deviation and the median and interquartile range. The comparison of the distributions of these variables between groups was performed using the Mann-Whitney test.

Detailed Description

The use of FBM, showing beneficial effects on wounds, is well described in the literature. The reported findings include anti-inflammatory action, better tissue organization, acceleration of angiogenesis, stimulation of leukocyte chemotaxis and reduction of donor area size in animals and humans. This is a clinical study with a controlled series of cases, whose objectives were: to evaluate the effects of FBM, using LED, on the repair process of the skin graft donor area treated with Membracel® and LED versus Membracel ®; to evaluate the evolution of the quality of the aspects of the skin donor area, through the score obtained by the modified Bates-Jensen Scale; the intensity of the pain reported by the participants; the size of the wound area until the 7th postoperative (PO) period and the time for re-epithelialization of the donor area. Data collection was performed at the Burn Unit of the General Hospital "Dr. José Pangella", from Vila Penteado, São Paulo, Brazil, from December 2018 to January 2020. The sample consisted of 21 participants and 25 donor areas, 13 of which were from the control group, which received only conventional treatment (Membracel®) and 12 from the experimental group: Membracel® and LED. Data collection instruments were used: medical records of the participants, anamnesis and physical examination, the scales: pain (Visual Analogic Scale - VAS) and Bates-Jensen to accompany the re-epithelialization process and the measurement of donor skin areas in the postoperative period. Participants were identified by Arabic numbers, according to the order of arrival at the Hospital. Quantitative variables were represented by the mean, standard deviation and the median and interquartile range. The comparison of the distributions of these variables between groups was performed using the Mann-Whitney test.

Conditions

Healing Wound

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LED group

The study had two groups of participants: the LED group (GL) and the control group (GC), both with Membracel®, a porous membrane that regenerates crystalline cellulose, as the primary cover in the donor area of the skin graft (no secondary cover was used) ). In one of the groups (GL), a light-emitting diode (LED) plate was applied, which was covered with sterile waterproof and transparent film to prevent contamination. The participant was positioned so that the skin graft donor area was accessible. The LED plate covered the entire skin donor area and was irradiated with a radiant exposure of 1.53J / cm2 and irradiance of 2.55 mW / cm2 for 10 minutes. The LED plate was applied in contact with the skin graft donor area in the immediate postoperative period and on Membracel® on the 1st, 3rd, 5th and 7th postoperative days. The primary coverage remained until spontaneous removal.

Group Type: EXPERIMENTAL

Membracel and LED photobiomodulation

Intervention Type: RADIATION

Participants were positioned so that the skin graft donor area was accessible. A light-emitting diode (LED) plate was covered with sterile transparent and waterproof film to prevent contamination when in contact with the donor area. The application was in contact, with full coverage of the surgical wound and was irradiated with radiant exposure of 1.53J / cm2 and irradiance of 2.55 mW / cm2 for 10 minutes. It is worth mentioning that the LED plate was applied in direct contact with the skin graft donor area in the immediate postoperative period and on the primary cover used (Membracel®) on the 1st, 3rd, 5th and 7th postoperative days. Coverage remained until spontaneous departure. The researcher and the participants used specific goggles for this procedure.

Control group

The participants remained and were evaluated under the same conditions. The only difference between the groups is that no LED photobiomodulation session was applied to the control group.

Group Type: OTHER

Membracel

Intervention Type: OTHER

This group did not receive LED application, remaining with the skin donor area covered by Membracel® and were evaluated under the same conditions.

Interventions

Membracel and LED photobiomodulation

Participants were positioned so that the skin graft donor area was accessible. A light-emitting diode (LED) plate was covered with sterile transparent and waterproof film to prevent contamination when in contact with the donor area. The application was in contact, with full coverage of the surgical wound and was irradiated with radiant exposure of 1.53J / cm2 and irradiance of 2.55 mW / cm2 for 10 minutes. It is worth mentioning that the LED plate was applied in direct contact with the skin graft donor area in the immediate postoperative period and on the primary cover used (Membracel®) on the 1st, 3rd, 5th and 7th postoperative days. Coverage remained until spontaneous departure. The researcher and the participants used specific goggles for this procedure.

Intervention Type: RADIATION

Membracel

This group did not receive LED application, remaining with the skin donor area covered by Membracel® and were evaluated under the same conditions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with burns requiring a partial thickness skin graft from a healthy donor area;
• Both sexes;
• Aged 18 years or older;
• Regardless of skin color or comorbidities.

Exclusion Criteria

• Patients with a full-thickness skin donor area;
• Under the age of 18;
• Those who refuse to participate;
• With infected wounds that evolved with purulent exudation during treatment;
• Cancer participants treated with radiation therapy or chemotherapy;
• With systemic infection;
• Corticosteroid use.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosadelia M Carboni, Student

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

University of Nove de Julho

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Rosadélia

Identifier Type: -

Identifier Source: org_study_id