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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05853237
Other study ID # P.T.REC/012/003308
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date January 19, 2023

Study information

Verified date May 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

LASER therapy is potent physiotherapy modalities, providing better sternotomy healing for patients who have undergone CABG surgery, compared with traditional wound care management alone. HLLT and LLLT were found to be the most effective methods for sternotomy healing post-CABG surgery, with HLLT offering superior performance in the case of the high deep penetration and significance less time needed to deliver the same joules/ cm compared to LLLT used for the wound site.


Description:

The aim of this study was to investigate the effects of class IV high-level laser therapy (HLLT) versus class IIIb low level laser therapy (LLLT) on sternotomy healing following coronary artery bypass grafting (CABG) surgery. Forty- five patients male patients who had CABG surgery in the age range of 45-65 years were divided randomly into three equal groups (n = 15). The group HLLT laser received HLLT plus traditional wound management, while the group LLLT laser received LLLT plus traditional wound management. The control group only received a traditional wound management in form of saline irrigation, dressing, and topical bivatracin spray according to hospital protocol. All groups were offered 10 sessions over 4 weeks. HLLT and LLLT were found to be the most effective methods for sternotomy healing post-CABG surgery, with HLLT offering superior performance in the case of the high deep penetration and significance less time needed to deliver the same joules/ cm compared to LLLT used for the wound site.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 19, 2023
Est. primary completion date December 24, 2022
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - aged between 45 and 65 years - male gender; haemodynamic stability - body mass index (BMI) from 18.5 to 29.9 kg/m2 - Non-infected sternotomy site - Normal ejection fraction to ensure normal vascularity. Exclusion Criteria: - included previous thoracic surgery - emergency or urgent coronary artery bypass surgery - respiratory insufficiency after surgery, manifesting hypoxemia with partial oxygen pressure in arterial blood < 60 mmHg; Ejection fraction < 50% - Paramedian sternotomy which may cut wire causing sternal mobilization which is the start of deep wound infection - Bilateral mammary harvesting which decrease blood flow to sternum; low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias or hypotension, according to the American College of Cardiology Foundation and American Heart Association - other medical conditions, such as diabetes, uncontrolled hypertension and obesity.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
laser therapy for wound management
comparison between laser effect on post median sternotomy incision compared to traditional wound care

Locations

Country Name City State
Egypt Kasr Al Aini University Hospital Giza

Sponsors (1)

Lead Sponsor Collaborator
Heidy F. Ahmed

Country where clinical trial is conducted

Egypt, 

References & Publications (28)

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14. Pryor BA. Advances in Laser Therapy for the treatment of work related injuries. Current Perspectives in Clinical Treatment and Management onWorkers' Compensation Cases, 1st edn. Bentham Science Publishers Ltd. 2011 Apr 23:191-201.

16. Mikolajczyk, Z., Nowak, I., Kawinski, A., & Mik, M. (2021). Phototherapy in the Treatment of Diabetic Foot-A Preliminary Study. Autex Research Journal, 21(4), 482-490.

23. Peplow P, Chung T, Baxter D. Application of low level laser technologies for pain relief and wound healing: Overview of scientific bases. Phys Ther Rev. 2000;15:4.

28. Baptista IDC, Chavantes MC, Dallan LDO, Stolf NAG (2009) Laser de baixa intensidade: nova tecnologia para os enfermeiros na cicatrizaçao pós-esternotomia. Rev Soc Cardiol Estado São Paulo 19:3-8

9. Pryor BA. Advances in Laser Therapy for the treatment of work related injuries. Current Perspectives in Clinical Treatment and Management onWorkers' Compensation Cases, 1st edn. Bentham Science Publishers Ltd. 2011 Apr 23:191-201.

Alayat MS, El-Sodany AM, Ebid AA, Shousha TM, Abdelgalil AA, Alhasan H, Alshehri MA. Efficacy of high intensity laser therapy in the management of foot ulcers: a systematic review. J Phys Ther Sci. 2018 Oct;30(10):1341-1345. doi: 10.1589/jpts.30.1341. Epub 2018 Oct 12. — View Citation

Amaroli A, Ravera S, Baldini F, Benedicenti S, Panfoli I, Vergani L. Photobiomodulation with 808-nm diode laser light promotes wound healing of human endothelial cells through increased reactive oxygen species production stimulating mitochondrial oxidative phosphorylation. Lasers Med Sci. 2019 Apr;34(3):495-504. doi: 10.1007/s10103-018-2623-5. Epub 2018 Aug 25. — View Citation

Bashardoust Tajali S, Macdermid JC, Houghton P, Grewal R. Effects of low power laser irradiation on bone healing in animals: a meta-analysis. J Orthop Surg Res. 2010 Jan 4;5:1. doi: 10.1186/1749-799X-5-1. — View Citation

Brocki BC, Thorup CB, Andreasen JJ. Precautions related to midline sternotomy in cardiac surgery: a review of mechanical stress factors leading to sternal complications. Eur J Cardiovasc Nurs. 2010 Jun;9(2):77-84. doi: 10.1016/j.ejcnurse.2009.11.009. Epub 2010 Jan 3. — View Citation

Chang VT, Sorger B, Rosenfeld KE, Lorenz KA, Bailey AF, Bui T, Weinberger L, Montagnini M. Pain and palliative medicine. J Rehabil Res Dev. 2007;44(2):279-94. doi: 10.1682/jrrd.2006.06.0067. — View Citation

Coulson SE, Adams RD, O'Dwyer NJ, Croxson GR. Physiotherapy rehabilitation of the smile after long-term facial nerve palsy using video self-modeling and implementation intentions. Otolaryngol Head Neck Surg. 2006 Jan;134(1):48-55. doi: 10.1016/j.otohns.2005.09.010. — View Citation

Cove ME, Spelman DW, MacLaren G. Infectious complications of cardiac surgery: a clinical review. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1094-100. doi: 10.1053/j.jvca.2012.04.021. Epub 2012 Jul 4. No abstract available. — View Citation

Dixit S, Maiya A, Umakanth S, Borkar S. Photobiomodulation of surgical wound dehiscence in a diabetic individual by low-level laser therapy following median sternotomy. Indian J Palliat Care. 2013 Jan;19(1):71-5. doi: 10.4103/0973-1075.110242. — View Citation

El-Ansary D, Waddington G, Adams R. Trunk stabilisation exercises reduce sternal separation in chronic sternal instability after cardiac surgery: a randomised cross-over trial. Aust J Physiother. 2007;53(4):255-60. doi: 10.1016/s0004-9514(07)70006-5. — View Citation

Fernandes GA, Lima AC, Gonzaga IC, de Barros Araujo R Jr, de Oliveira RA, Nicolau RA. Low-intensity laser (660 nm) on sternotomy healing in patients who underwent coronary artery bypass graft: a randomized, double-blind study. Lasers Med Sci. 2016 Dec;31(9):1907-1913. doi: 10.1007/s10103-016-2069-6. Epub 2016 Sep 20. — View Citation

Helmy ZM, Mehani SHM, El-Refaey BH, Al-Salam EHA, Felaya EEE. Low-level laser therapy versus trunk stabilization exercises on sternotomy healing after coronary artery bypass grafting: a randomized clinical trial. Lasers Med Sci. 2019 Aug;34(6):1115-1124. doi: 10.1007/s10103-018-02701-4. Epub 2018 Dec 13. — View Citation

Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 6;124(23):2610-42. doi: 10.1161/CIR.0b013e31823b5fee. Epub 2011 Nov 7. No abstract available. Erratum In: Circulation. 2011 Dec 20;124(25):e956. Circulation. 2012 Aug 14;126(7):e105. — View Citation

Hon J, Lagden K, McLaren AM, O'Sullivan D, Orr L, Houghton PE, Woodbury MG. A prospective, multicenter study to validate use of the PUSH in patients with diabetic, venous, and pressure ulcers. Ostomy Wound Manage. 2010 Feb 1;56(2):26-36. — View Citation

Kazemi Khoo N, Babazadeh K, Lajevardi M, Dabaghian FH, Mostafavi E. Application of Low-Level Laser Therapy Following Coronary Artery Bypass Grafting (CABG) Surgery. J Lasers Med Sci. 2014 Spring;5(2):86-91. — View Citation

Liao X, Xie GH, Liu HW, Cheng B, Li SH, Xie S, Xiao LL, Fu XB. Helium-neon laser irradiation promotes the proliferation and migration of human epidermal stem cells in vitro: proposed mechanism for enhanced wound re-epithelialization. Photomed Laser Surg. 2014 Apr;32(4):219-25. doi: 10.1089/pho.2013.3667. Epub 2014 Mar 24. — View Citation

Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available. — View Citation

Olbrecht VA, Barreiro CJ, Bonde PN, Williams JA, Baumgartner WA, Gott VL, Conte JV. Clinical outcomes of noninfectious sternal dehiscence after median sternotomy. Ann Thorac Surg. 2006 Sep;82(3):902-7. doi: 10.1016/j.athoracsur.2006.04.058. — View Citation

Renno AC, McDonnell PA, Parizotto NA, Laakso EL. The effects of laser irradiation on osteoblast and osteosarcoma cell proliferation and differentiation in vitro. Photomed Laser Surg. 2007 Aug;25(4):275-80. doi: 10.1089/pho.2007.2055. — View Citation

Sa MP, Silva DO, Lima EN, Lima Rde C, Silva FP, Rueda FG, Escobar RR, Cavalcanti PE. Postoperative mediastinitis in cardiovascular surgery postoperation. Analysis of 1038 consecutive surgeries. Rev Bras Cir Cardiovasc. 2010 Jan-Mar;25(1):19-24. — View Citation

Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016 Jul;4(13):256. doi: 10.21037/atm.2016.06.33. — View Citation

Tucker LD, Lu Y, Dong Y, Yang L, Li Y, Zhao N, Zhang Q. Photobiomodulation Therapy Attenuates Hypoxic-Ischemic Injury in a Neonatal Rat Model. J Mol Neurosci. 2018 Aug;65(4):514-526. doi: 10.1007/s12031-018-1121-3. Epub 2018 Jul 22. — View Citation

Veith AP, Henderson K, Spencer A, Sligar AD, Baker AB. Therapeutic strategies for enhancing angiogenesis in wound healing. Adv Drug Deliv Rev. 2019 Jun;146:97-125. doi: 10.1016/j.addr.2018.09.010. Epub 2018 Sep 26. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary PUSH pressure ulcer scaling healing score for wound healing measure wound surface area in cm 2 two consecutive months
Primary PUSH pressure ulcer scaling healing score for wound healing measure wound exudate in percent two consecutive months
Secondary VAS visual analogue scale visual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain) two consecutive months
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