WoundwoundsNCT05853237
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bybass Graft
A study testing laser therapy for wound management in people with Wound and Wound Heal, run by Heidy F. Ahmed at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Wound, Wound Heal, Wound Infection
- What is being tested?
- laser therapy for wound management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bypass Graft: a Randomize Control Trail
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.
Read the detailed 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.
- Conditions
- Wound, Wound Heal, Wound Infection
- Being tested
- laser therapy for wound management
- Keywords
- Coronary arteries bypass grafting, high level laser therapy, Low-level laser therapy, Median sternotomy healing
- Medical subject headings
- Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapy for wound managementDevice
comparison between laser effect on post median sternotomy incision compared to traditional wound care
| Study group | Role | What they receive |
|---|---|---|
| class IV group | Experimental | start from day one surgery for 4 successive weeks, the goal in the phase I (1st 10 days after surgery) is decontamination, improve circulation, pain reduction \&wound healing acceleration The goal of phase II (next10 days till complete healing) is improve osteo-integration, pain reduction \& enhance superficial collagen production to decrease scarring. The parameters are: Power > 500 mW; fluence 20 joule/ cm2 with (980, 915, 810 nm) and 5 joules/ cm2 by 650 nm; mode (continuous); hand piece radius = 2.5 cm; spot size (Area) = 5 cm; application by scanning not spotting to avoid thermal effect and time of session is 5- 10 minutes Receives: Device: laser therapy for wound management |
| class IIIb | Experimental | Use the same protocol as in HLLT with the same wave lengths but with low power Power = 200- 300 mW; fluence 20 joule/ cm2 with (980, 915, 810 nm) and 5 joules/ cm2 by 650 nm; mode (continuous); hand piece radius = 2.5 cm; spot size (Area) = 5 cm; application by spotting and time of session was 25- 30 minutes. Receives: Device: laser therapy for wound management |
| traditional wound care | Active comparator | According to the hospital protocol Irrigation of the wound by normal saline, betadine application, bivatracin spray and Change dressing daily to protect the wound from infection Receives: Device: laser therapy for wound management |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUSH pressure ulcer scaling healing score for wound healing
measure wound surface area in cm 2
Measured: two consecutive months
PUSH pressure ulcer scaling healing score for wound healing
measure wound exudate in percent
Measured: two consecutive months
Secondary outcomes (1)
VAS visual analogue scale
visual analogue scale of the pain in numbers from 1-10(10 max pain and 1 min pain)
Measured: two consecutive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Nov 2021
- Primary completion24 Dec 2022
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group A receive laser therapy class IV+traditional wound care and group (B): Laser therapy class IIIb + traditional wound care and group C receive only traditional wound care
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidy F. Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heidy F. Ahmed, Cairo University
- Investigators
- Heidy F Ahmed, master, Principal investigator, Kasr al aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853237
- Sponsor's protocol ID
- P.T.REC/012/003308
- Acronym
- wounds
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD), all IPD that underlie results in a publication
Publications
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.
PubMed 27500157Olbrecht 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.
PubMed 16928505Cove 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.
PubMed 22765993Mazzeffi 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.
PubMed 21955825Brocki 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.
PubMed 20051323Chang 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.
PubMed 17551879Amaroli 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.
PubMed 301457259. 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.
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.
PubMed 24661127Veith 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.
PubMed 3026774212. Johnson JF. Laser therapy and pain management. Laser Therapy in Veterinary Medicine: Photobiomodulation. 2017 May 11:75-87.
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.
PubMed 3003239714. 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.
PubMed 3034917616. Mikołajczyk, Z., Nowak, I., Kawiński, A., & Mik, M. (2021). Phototherapy in the Treatment of Diabetic Foot-A Preliminary Study. Autex Research Journal, 21(4), 482-490.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bypass Graft: a Randomize Control Trail
- ClinicalTrials.gov ID
- NCT05853237
- Acronym / sponsor ID
- wounds / P.T.REC/012/003308
- Conditions
- Wound, Wound Heal, Wound Infection
- Keywords
- Coronary arteries bypass grafting, high level laser therapy, Low-level laser therapy, Median sternotomy healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heidy F. AhmedUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- group A receive laser therapy class IV+traditional wound care and group (B): Laser therapy class IIIb + traditional wound care and group C receive only traditional wound care
| Arm | Type | Receives |
|---|---|---|
| class IV group | Experimental | Device: laser therapy for wound managementstart from day one surgery for 4 successive weeks, the goal in the phase I (1st 10 days after surgery) is decontamination, improve circulation, pain reduction \&wound healing acceleration The goal of phase II (next10 days till complete healing) is improve osteo-integration, pain reduction \& enhance superficial collagen production to decrease scarring. The parameters are: Power > 500 mW; fluence 20 joule/ cm2 with (980, 915, 810 nm) and 5 joules/ cm2 by 650 nm; mode (continuous); hand piece radius = 2.5 cm; spot size (Area) = 5 cm; application by scanning not spotting to avoid thermal effect and time of session is 5- 10 minutes |
| class IIIb | Experimental | Device: laser therapy for wound managementUse the same protocol as in HLLT with the same wave lengths but with low power Power = 200- 300 mW; fluence 20 joule/ cm2 with (980, 915, 810 nm) and 5 joules/ cm2 by 650 nm; mode (continuous); hand piece radius = 2.5 cm; spot size (Area) = 5 cm; application by spotting and time of session was 25- 30 minutes. |
| traditional wound care | Active comparator | Device: laser therapy for wound managementAccording to the hospital protocol Irrigation of the wound by normal saline, betadine application, bivatracin spray and Change dressing daily to protect the wound from infection |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser therapy for wound managementcomparison between laser effect on post median sternotomy incision compared to traditional wound care | Device | class IIIb, class IV group, traditional wound care |
Primary outcome
PUSH pressure ulcer scaling healing score for wound healing
Time frame: two consecutive months
measure wound surface area in cm 2
PUSH pressure ulcer scaling healing score for wound healing
Time frame: two consecutive months
measure wound exudate in percent
1 secondary outcome
VAS visual analogue scale
Time frame: two consecutive months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 27500157Sanchis-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.
- Background: PubMed 16928505Olbrecht 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.
- Background: PubMed 22765993Cove 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.
- Background: PubMed 21955825Mazzeffi 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.
- Background: PubMed 20051323Brocki 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.
- Background: PubMed 17551879Chang 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.
- Background: PubMed 30145725Amaroli 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.
- Background9. 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.
- Background: PubMed 24661127Liao 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.
- Background: PubMed 30267742Veith 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.
- Background12. Johnson JF. Laser therapy and pain management. Laser Therapy in Veterinary Medicine: Photobiomodulation. 2017 May 11:75-87.
- Background: PubMed 30032397Tucker 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.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD), all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidy F Ahmed, master principal investigator
Kasr al aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy for wound management in people with Wound and Wound Heal, run by Heidy F. Ahmed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PUSH pressure ulcer scaling healing score for wound healing (time frame: two consecutive months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853237, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.