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Laser and LED on the healing of cardiac surgery incision

Photobiomodulation with the use of low-level laser and LED in the sternotomy and saphenous repair process of postoperative patients in coronary artery bypass grafting

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-38wgx6
Enrollment
Unknown
Registered
2012-05-01
Start date
2011-10-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing, dehiscence, pain, inflammation, infection

Interventions

Participants were divided into four groups with equal number of participants, being 30 per group, and 120 in total, allocated as follows: Group 01 were subjected to phototherapy with light emitted di
Group 02 received laser phototherapy application of 660nm wavelength and intensity of 6 J/cm2 in the immediate postoperative period, second, fourth and sixth day after surgery and 48 hours after hosp
Group 3 received placebo, with phototherapy equipment switched off, attending the same protocol of group 01
and group 4 were accompanied only clinically.
Device
H02.010.625
E02.774

Sponsors

Faculdade Novafapi
Lead Sponsor
Universidade do Vale do Paraíba
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Were included 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

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 refused to participate.

Design outcomes

Primary

MeasureTime frame
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 pain were 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 local temperature and hyperemia were recorded by an infrared thermometer with laser aim.;The quality of life were assessed at the preoperatory period and one month after hospital discharge using the SF36 Questionnaire adapted and translated into Portuguese.

Secondary

MeasureTime frame
In the case of dehiscence, culture with the local material collected were performed by a swab in order to identify the presence of infectious agents.

Countries

Brazil

Contacts

Public ContactAndréa ;Gilderlene Gomes Lims;Fernandes

Universidade do Vale do Paraíba;Universidade do Vale do Paraíba

andreacglima@hotmail.com;gilderlene@yahoo.com.br+558699978142;+558699954401

Outcome results

None listed

Source: REBEC (via WHO ICTRP)