LED on the healing of cardiac surgery incision

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-38wgx6
• Date of registration: 01/05/2012
• Primary sponsor: Faculdade Novafapi - Teresina, PI, Brazil
• Public title: LED on the healing of cardiac surgery incision
• Scientific title: Photobiomodulation with the use of LED in the sternotomy and saphenous repair process of postoperative patients in coronary artery bypass grafting
• Date of first enrolment: 25/10/2011
• Target sample size: 90
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-38wgx6/
• Study design: Three armed randomised clinical trial, prospective, double-blind, therapeutic intervention, controlled and with placebo.

Countries of recruitment

Brazil

Contacts

• Name: Rauirys Oliveira
• Affiliation: Universidade do Vale do Paraíba

• Name: Rauirys Oliveira
• Affiliation: Universidade do Vale do Paraíba

Key inclusion & exclusion criteria

Inclusion criteria: individuals who perform elective coronary artery bypass grafting with saphenous vein graft, undergoing cardiopulmonary bypass, hemodynamically stable and who agree to participate in the study by signing the Consent Term.
Exclusion criteria: Diabetic, morbidly obese with a body mass index (BMI) greater than 40 kg/m2, history of previous thoracic surgery, urgent and emergency surgery, respiratory failure, renal failure, low cardiac output syndrome, need for circulatory assistance using of intra-aortic balloon, subjects who developed complications that resulted in changes to the protocol of analgesia, those showing the period of preoperative hospitalization over 48 hours, presence of coagulopathy, malignancy, renal failure, respiratory tract infections, urinary and endocarditis, as well as those who refuse to participate.

Age minimum: 18Y
Age maximum: 75Y
Gender: -

Health Condition(s) or Problem(s) studied

Healing, dehiscence, pain, inflammation, infection
C23.550.767.887
G16.100.856.891
E04.100.376.719

Intervention(s)

Participants will be divided into three groups of 30 individuals each in a total of 90 participants, allocated as follows: group 01 will be subjected to therapy with LED 660 wave lenght nm and intensity of 6 J/cm2 at the immediate postoperative period, second, fourth and sixth postoperative days and 48 hours after discharge; a group 02 will receives a placebo, with the LED equipment off, according to the same protocol of group 01; group 3 only will be accompanied clinically.

Primary Outcome(s)

Area of surgical incision: The incision will be recorded by digital photography and analyzed with the software ImageJ 1.43u in terms of the area, presence or absence of dehiscence and hyperemia.

The local temperature and hyperemia will be recorded by an infrared thermometer with laser aim.

The pain will be evaluated in terms of their intensity and their sensory, affective and evaluative descriptors, using Visual Analogue Scale (VAS) and McGill pain questionnaire translated and adapted into Portuguese.

The quality of life will be assessed at the preoperatory period and one month after hospital discharge using the SF36 Questionnaire adapted and translated into Portuguese.

Secondary Outcome(s)

In the case of dehiscence, we will make culture with the local material collected by a swab in order to identify the presence of infectious agents.

Secondary ID(s)

0120.0.043.000-11

166/11

Source(s) of Monetary Support

Faculdade Novafapi - Teresina, PI, Brazil

Secondary Sponsor(s)

Universidade do Vale do Paraíba - São José dos Campos, SP, Brazil