Patient information

Low-level laser therapy and skin replacement therapies (Kerecis® Omega 3 fish skin therapy) for the advanced management of wounds, ulcers and lymphoedema therapy:

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Published: November 2022
If you need any more information, please feel free to ask.

Background:

Complex wounds and complex lymphoedema are a collection of diseases with major effect on quality of life. Complex wounds are those which do not respond to standard dressings and/or surgical treatment despite all efforts. The wound attracts bacteria which become more resistant to many types of treatments available. In lymphoedema, the legs or arms become swollen due to partial or complete blockage of lymph channels. The skin and other soft tissue suffer from recurrent attacks of inflammation. This blocks the lymph channels further. The fluid starts to leak out from the skin, and an excessive repair mechanism takes place. The skin become thick, solid and pigmented (medically known as lipodermatosclerosis). The effect on quality of life is huge.
The standard therapy for complex wounds and ulcers consists of pressure off‐loading (keeping weight off the area debridement (removal of dead tissue), infection control, the use of wound dressings or topical agents, intensive regulation of blood glucose where needed treatment of any underlying vein disease (where possible) and ‐ in the case of ischaemia ‐ vascular reconstruction. The standard therapy for lymphoedema consists of patient education, made-to-measure compression stockings, skin care, and limb exercises.
This multidisciplinary approach differs among patients due to different treatment modalities, treatment intensity and patient adherence.
Low level laser therapy (LLLT) uses low-energy lasers, on the skin and/or wounds, to treat the affected tissue. The aim is to reduce inflammation and stimulate the healing process. Skin grafts and tissue replacements are methods used to reconstruct skin defects for people with large non healing wounds and ulcers in addition to providing them with standard care. Skin substitutes can consist of bioengineered or artificial skin, autografts (taken from the patient), allografts (taken from another person) or xenografts (taken from animals).
The overall therapeutic effect of skin grafts and tissue replacements used in conjunction with standard care has been shown in systematic reviews to increase the healing rate of ulcers and slightly fewer amputations in people with diabetes, for example, compared with standard care alone. Certain limitations in available evidence are discussed later.

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Is this therapy NICE-approved? –

Low level laser and Kerecis® Omega 3 fish skin therapies are not yet approved by the National Institute for Clinical Excellence (NICE) on lymphoedema or complex wounds due to lack of robust high-level evidence. The therapy is used in both the NHS and Private sectors on selected patients.1 Such therapies can be linked to considerable uncertainty and, inevitably, a perceived risk. Patient safety requires that risk is assessed, communicated, and as far as possible, reduced. Our service on low level laser and Kerecis® Omega 3 fish skin therapies are subject to rigorous governance checks to ensure that patients are having a multidisciplinary approach, appropriate informed consent process, monitoring of therapy applications and outcome, rigorous safety measures, implementing of audit cycles, and a thorough documentation practice of actions and therapies applied

Is this therapy right for me? Is it suitable/offered to everyone?

This therapy is specifically designed for and only provided to complex wounds that are resistant to treatment, as well as symptomatic or complicated lymphoedema that has not responded to traditional medical therapy. Once you’ve been offered this procedure, the professional team will discuss with you what is involved and tell you about the risks and benefits. They will talk with you about your options and listen carefully to your views and concerns. Your family can be involved too, if you wish. All of this will happen before you agree (consent) to have the procedure. You should also be told how to find more information about the procedure. Please refer to this useful guidelines on making decisions about your care (https://www.nice.org.uk/about/nice-communities/nice-and-the-public/making-decisions-about-your-care).

How does it work?

Laser therapy has not been researched extensively yet. Current understanding from different studies (with different level of strength) is that laser therapy can help reducing the volume of swollen limbs, breaking down scar and thickened tissues, as well as increasing range of range of motion as it reduces the tightness. Other research studies have shown that the low-level laser beam can increase the flow of lymph fluid, reduces the amount of excessive protein in the fluid and reduces the tendency of scar tissue to get stuck to the underlying healthy tissue.1
It is believed that the laser beam can target individual components within the cells and ‘re-energises’ them to work more effectively. This helps to regulate the scar tissue better and promote uptake of fluid. 1

What does the procedure involve?

In your initial visit, you will be reviewed by our consultants (multidisciplinary approach). You will be reviewed by our trained nurses as well. Measurements and photos will be taken. Once all investigations are done, you will be taken through the findings and a treatment plan will be discussed with you and put in writing. Where needed and deemed essential, you will be offered treatment for venous disease, arterial disease, and skin condition disease as appropriate.
The low-level laser therapy and/or Kerecis® application will take place in the minor op and/or treatment room. The duration of each session is about 60 minutes. You will be asked to lye down comfortably. A full personal protective equipments (PPEs) will be used. A Chaperon will be offered. The lymphoedema therapist will place the device on specific areas, shown and agreed by you, directly onto your skin.
The areas are related to the lymphatic channels and follows recommendations from the laser manufacturer. Several areas of the skin will usually be treated for approximately 1 minute each with a varying treatment time. Other modalities of treatment will also be used to support the laser treatment. Those include non-invasive dynamic compression to the limb, skin creams and drainage of lymphatic fluid, low level shockwave therapy for lymphoedema (this will take place in the physiotherapy room), ultrasonic and infra-red wave therapy, as well as other non-invasive modalities.
Where Kerecis® is planned, the wound will be assessed and treated using approved standard of care. Kerecis® will be implanted in a sterile manner and fitted into the wound. A suitable dressing will be used. A schedule for dressing changes will be provided to you by the therapist.

What will it feel like?

Laser therapy and the supporting therapies does not hurt. Slight discomfort might be felt if the shockwave therapy is used. Some people have reported a slight warmth or tingling feeling. There is no expected downtime after the therapy. You are expected to resume your usual daily activates after the session. If Kerecis® is used, you are not unexpected to feel any different from applying a standard dressing. Side effects can occur and are detailed later this leaflet.

What are the possible benefits? How likely am I to get them?

Low level laser therapy (LLLT) uses low-energy lasers, on the skin and/or wounds, to treat the affected tissue. The aim is to reduce inflammation and stimulate the healing process.
A recent review study (Aug 2022) on lymphoedema patients (related to breast cancer-related lymphoedema) have shown that at four weeks, there was a considerable reduction in arm circumference/volume, and this continued with long-term follow-up. [BMC Cancer. 2022 Aug 30;22(1):937]
Nevertheless, the results vary in patients, and the numbers included in those studies are limited with limited follow up.
Our specialists have experienced, and audited, similar range of change in their treated patients. However, like any other medical treatment, this is not guaranteed. The treatment will be provided at the highest standards possible and will follow the instructions published by UK-licensed laser manufacturer. This will be in addition to applying best standard of approved care for wound management and/or lymphoedema therapy.

How long does it take to work?

As mentioned above, research has shown that the benefits are most often felt few weeks to 3 months after beginning the treatment.1 However, you may notice an immediate effect after the first treatment. More commonly patients report a gradual improvement over the 1st to 6th weeks of treatment, with many seeing improvement by day 4 or week 2 of treatment, and this improvement should continue.1
Does laser therapy or Kerecis® work for everyone?
Laser therapy and/or Kerecis® Omega 3 Wound does not work for some people. The team will evaluate your treatment response and keep you informed on the progress.
What are the risks or side effects from laser therapy? How likely are they?
There has been no serious harm noticed in using this non-invasive therapy. We have noticed occasional formation of blisters which healed up smoothly. We have noticed some patients developed bruise-like feeling. There has been no reported infection or bleeding associated with the treatment.
What are the risks or side effects from Kerecis® Fish skin therapy?
Kerecis® Omega 3 Wound is derived from a fish source and should not be used in patients with a known allergy or other sensitivity to fish material.
The following complications are possible. If any of these conditions occur, Kerecis® Omega 3 should be removed.
• Infection
• Chronic inflammation
• Allergic reaction
• Excessive redness, pain, swelling, or blistering

What happens if I don’t want the procedure? Are there other treatments available?

Your team will advise you on best standard of care for wounds and lymphoedema. Feel free to ask questions where any part of your treatment is not clear.

Caution

As with other lymphoedema treatments, it’s never a good idea to try to use a commercially available laser therapy device on your own.

Further information

1. Low Level Light Therapy (LLLT, laser therapy) for Lymphoedema Patients. Northern Devon Healthcare NHS Trust. https://www.northdevonhealth.nhs.uk/wp-content/uploads/2016/09/Laser-therapy-for-lymphoedema-patients.pdf
2. British Lymphology Society − www.lymphoedema.org/bls
3. Lymphoedema Support Network – www.lymphoedema.org/lsn
4. Macmillan Cancer Relief – www.macmillan.org.uk
5. NHS Choices – www.nhs.uk/conditions/lymphoedema
6. Kerecis®® instructions for use (IFU) – https://www.Kerecis®.com/wp-content/uploads/2021/07/Instructions-for-Use-IFU.pdf

The Evidence – 

Here is the research evidence on which our recommendation is based.

The current level of evidence is: I. The recommendation grade is: B. 

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NICE Research Portal: 

The National Institute for Health and Clinical Excellence (NICE) has identified the following randomised trials and systematic reviews in relation to using LLLT in lymphoedema patients, with the outcome of treatment as follows:

RANDOMISED CONTROLLED TRIALS – 

  • Low level laser therapy for the management of breast cancer-related lymphedema: A randomized controlled feasibility study.  Lasers Surg Med 2018. All participants who completed LLLT (PBM) treatment indicated that they were satisfied with the treatment. No serious adverse reactions were reported in this study.
  • Photobiomodulation Therapy (PBMT) in breast cancer-related lymphedema: a randomized placebo-controlled trial.  Photodermatol Photoimmunol Photomed 2016 Dec 10.  Results: Post-treatment, a 50% reduction in median pain scores and an increase in mean quality of life were observed. Mean grip strength was persistently higher after eight sessions of PBMT compared to pretreatment. The study did not reach a statistically significant level though.
  • A pilot randomized trial evaluating low-level laser therapy as an alternative treatment to manual lymphatic drainage for breast cancer-related lymphedema. Oncol Nurs Forum 2013 Jul 1 40(4) 383-93. Conclusions: LLLT with bandaging may offer a time-saving therapeutic option to conventional MLD. Lasers may provide effective, less burdensome treatment for lymphedema. Practitioners with lymphedema certification can effectively treat this patient population with the use of LLLT.
  • Treatment of Post-Mastectomy Lymphedema with Laser Therapy: Double Blind Placebo Control Randomized Study. J Surg Res 2010 Apr 18. CONCLUSION: Laser treatment was found to be effective in reducing the limb volume, increase shoulder mobility, and hand grip strength in approximately 93% of patients with postmastectomy lymphedema.
  • Managing postmastectomy lymphedema with low-level laser therapy. A prospective, single-blinded, controlled clinical trial.  Photomed Laser Surg 2009 Oct 27(5) 763-9 . RESULTS: Reduction in arm volume and increase in tissue softening was found in the laser group only. At the follow-up session, significant between-group differences (all p < 0.05) were found in arm volume and tissue resistance at the anterior torso and forearm region. The laser group had a 16% reduction in the arm volume at the end of the treatment period, that dropped to 28% in the follow-up. Moreover, the laser group demonstrated a cumulative increase from 15% to 33% in the tonometry readings over the forearm and anterior torso. The DASH score of the laser group showed progressive improvement over time. CONCLUSION: LLLT was effective in the management of PML, and the effects were maintained to the 4 wk follow-up.

SYSTEMATIC REVIEWS – 

  • A systematic review of common conservative therapies for arm lymphoedema secondary to breast cancer treatment. Database of Abstracts of Reviews of Effects – DARE – 03 November 2008. Via. NICE: evidence.nhs.uk.
    • Results: Low-level laser therapy (3 studies): study quality ranged from 5 to 8. All studies (including one double-blinded, randomised placebo-controlled trial) reported benefits from low-level laser therapy including volume reduction and improved subjective symptoms and quality of life.
  • Clinical effectiveness of decongestive treatments on excess arm volume and patient-centered outcomes in women with early breast cancer-related arm lymphedema: a systematic review (2018). JBI Database of Systematic Reviews and Implementation Reports: February 2018 – Volume 16 – Issue 2 – p 453–506. The treatment of lymphedema with low level laser therapy is thought to have a multi-factorial effect to increase lymph flow and thereby reduce tissue fluid and proteins. Evidence for the benefit of low level laser therapy give it a grade B recommendation.
  • Low level laser therapy (Photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review.  BMC Cancer 2017 Dec 07. CONCLUSIONS: Based upon the current systematic review, LLLT (PBM) may be considered an effective treatment approach for women with BCRL. Due to the limited numbers of published trials available, there is a clear need for well-designed high-quality trials in this area.
  • Current Treatments for Breast Cancer-Related Lymphoedema: A Systematic Review.Asian Pac J Cancer Prev 2016 11 01 17(11) 4875-4883. Results: Combined physical therapy (CPT) with different combinations of surgery, oral pharmaceuticals, low-level laser therapy, weight reduction, mesenchymal stem cell therapy, kinesio tex taping, and acupuncture might be effective in reducing lymphoedema.
  • Effect of low-level laser therapy on pain and swelling in women with breast cancerrelated lymphedema: a systematic review and meta-analysis. J Cancer Surviv 2014 Nov 29.  CONCLUSION: Moderate-strength evidence supports LLLT in the management of BCRL, with clinically relevant within-group reductions in volume and pain immediately after conclusion of LLLT treatments. Greater reductions in volume were found with the use of LLLT than in treatments without it. IMPLICATIONS FOR CANCER SURVIVORS: LLLT confers clinically meaningful reductions in arm volume and pain in women with BCRL.

CLINICAL GUIDELINES – 

  •  International Consensus – Best Practice for the Management of Lymphoedema (2006): Low level laser therapy has shown potential for the treatment of lymphoedema, particularly of the upper limb, where it has reduced limb volume and tissue hardness.
  •  Lymphoedema cancer guidelines (US. 2015). Low-level laser therapy was recommended as a therapeutic option for cancer patients with lymphoedema, giving it a Level of evidence: I. Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately one-third of patients with postmastectomy lymphedema at 3 months posttreatment. Suggested rationales for laser therapy include a potential decrease in fibrosis, stimulation of macrophages and the immune system, and a possible role in encouraging lymphangiogenesis. (https://www.cancer.gov/about-cancer/treatment/side-effects/lymphedema/lymphedema-hp-pdq#_68_toc)
  • Lymphoedema support network (2019 – https://www.lymphoedema.org/index.php/information-and-support/useful-articles#alternativetherapies) – LLLT has anecdotally been reported as being beneficial to treat pain and increase range of movement e.g. in softening the skin and scar tissue in head and neck lymphoedema (following surgery and/or radiotherapy) to increase head turn and improve posture/discomfort. LLLT should be given regularly to start with, e.g. 2-5 times in the first 2-3 weeks and then may be reduced over time. The LLLT probe (different sizes exist from a small pen type probe to one that looks like a shower head) is held on the skin in each affected area for 1 minute, with a total treatment time of 10-30 minutes.
  • Commissioning guidelines for lymphoedema service in the UK (2019. https://thebls.com/documents-library/commissioning-guidance-for-lymphoedema-services-for-adults-in-the-united-kingdom) recommend considering additional and novel treatment components such as low level laser therapy, intermittent pneumatic compression, medical taping and oscillation therapy. Although quality evidence is limited, the BLS believes that anecdotal reports indicate benefit to patients.
  • The Consensus document (2016) of the international society of lymphology – (https://journals.uair.arizona.edu/index.php/lymph/article/view/20106/19734) Reports on LLLT with small meta-analysis have demonstrated efficacy of low level laser use for patients with lymphedema. More robust changes are noted with reduction of pain and mobility of tissue than just pure lymphedema volume reduction.
    • For more info, please contact us on this link.
    • Also find included our leaflet for the programme.

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Lymphoedema and Lymphovenous Oedema