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

NCT03699852 | Completed

• 1 other identifier: Rosadélia
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Wound

Outcome Measures

Primary Outcomes (3)

• Change in the Bates-Jensen Wound Assessment Tool (BWAT)

  This scale evaluates size, depth, edges, detachment, type and amount of necrotic tissue, type and amount of exudate, edema and hardening of the peripheral tissue, skin color around the wound, granulation tissue and epithelization. The measurement scale is of the Likert type, with five points, with 1 indicating the best condition of the wound and 5, the worst condition. The total score is obtained with the sum of all the items and can vary from 13 to 65 points, with the highest scores indicating the worst conditions of the wound. The items: size, depth, edges, and detachment should be scored with zero when the lesions are healed. The instrument contains two items: location and form - which are not part of the total score.

  Every two days until wound reepithelialization

• Change in the Analogic visual scale

  The scale allows for "validation" by the participant, as he or she experiences pain and is therefore an expert on the pain pattern, location, intensity and nature.

  Every two days, until the 7th day after the procedure.

• Time for donor area reepithelialization

  The LED Group and Control Group donor areas were evaluated for time to reepithelialization. They were considered completely reepithelized when no exudate was noted, the participant reported no pain with exposure of the wound to ambient air and was completely devoid of Membracel coverage and hematic crusts.

  Once a week

Study Arms (2)

LED group

EXPERIMENTAL

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.

Radiation: Membracel and LED photobiomodulation

Control group

OTHER

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.

Other: Membracel

Interventions

Membracel and LED photobiomodulation 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.

LED group

Membracel OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, 01504000, Brazil

Location

Study Officials

• Rosadelia M Carboni, Student

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: December 11, 2018
• Primary Completion: November 15, 2019
• Study Completion: January 10, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)