Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds

Diabetic Foot Ulcer Clinical Trial

Official title:

Efficacy of the Er:YAG Laser Debridement on Patient-Reported Pain and Bacterial Load in Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182582
• Other study ID #: IRB-35141
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: March 17, 2017

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bacterial load is frequently associated with impaired healing of chronic wounds. As well, sharp debridement is often associated with pain, causing patient distress, and thereby occasionally contributing to inadequacy of debridement, leading to a delay in wound healing. The purpose of this study is to assess the efficacy of the Sciton Laser in reducing bacterial load and patient distress in patients with chronic wounds, in efforts to expedite the wound healing process.

Description:

Chronic wounds are a debilitating affliction, affecting a substantial portion of the population worldwide and incurring staggering healthcare economic costs (1,2). Included among chronic wounds are venous leg ulcers, which are known to cause considerable pain, and can impact patient quality of life, thereby complicating wound care (3). The exact pathophysiology and etiology of the prolonged course of chronic wounds are poorly understood, but are thought to be multi-factorial in nature. Given the exposure of chronic wounds to the environment, they harbor a diverse microbial flora. Specifically, there is evidence that biofilm produced by these microbes are a large contributor to their non-healing nature (4). Debridement is considered an integral part of wound management with its ability to remove necrotic tissue and bacterial biofilm, in addition to stimulating release of cytokines and growth factors that promote wound healing (5). However, sharp debridement, the gold standard in wound care, is often ineffective for painful wounds.

The effect of lasers on wound healing have been well-studied both in in vitro and in vivo models. Beneficial effects of low-level laser therapy in wound healing in animal and human studies has been established. However, extrapolation of this data is limited by study design and light dosimetry (6). Laser energy used for surgical excision is a lesser-known debridement technique that has been largely limited to burn scar treatment (7,8,9,10). Lasers are electro-optical devices that emit a focused beam of intense monochromatic light in the visible and infrared radiation spectrums. Since their start in the 1960s, lasers have been successfully utilized in many fields of medicine. Lasers for wound debridement began in the 1970s, with the successful report of a continuous-beam carbon dioxide (CO2) laser used for skin graft preparation of infected decubitus ulcers (11). Laser debridement is based on the controlled vaporization of the superficial layers of the wound bed. This results in the removal of the tissue containing unwanted microbial and necrotic particles. The laser type and the number of passes performed determine the depth of tissue ablation (12). Unlike other methods dependent on the clinician's manual control, laser debridement is electronically controlled, improving precision and reducing the risk of healthy tissue damage. Advantages of laser debridement include precision and uniformity of tissue ablation, which reduces trauma to the wound bed, improving patient comfort. To reduce thermal damage to healthy tissue, several improvements in laser technology have been made over the years. By utilizing a pulsed-beam system, laser energy is delivered in high-power, rapid succession pulses, resulting in short duration and high temperature exposure of target tissue, thereby minimizing thermal injury.

Erbium:YAG (Er:YAG) lasers, with a wavelength of 2940-nm are widely used in the dermatologic community for skin resurfacing, for anti-aging and acne-related purposes (13). Skin ablation with the erbium laser is very precise, and allows for accurate assessment of the resurfacing depth (12,14,15). Since Er:YAG laser energy has greater than twelve times more water absorption efficiency than CO2 lasers, water in the tissue is rapidly expanded to eject the charred debris from the wound surface without leaving behind a necrotic eschar (12,16,17). The Er:YAG laser provides distinct advantages in precise ablation control and the reduction of residual necrotic tissue burden with minimal procedural discomfort, making the Er:YAG laser the most suitable device for laser wound debridement. Preliminary studies demonstrate remarkable patient pain reduction after laser debridement, resulting in more thorough removal of necrotic tissue and biofilm/bacterial load. Additionally, the extent of laser debridement is determined by the laser settings, as opposed to the individual operator's dexterity and skill, thereby providing better control over the wound bed preparation, producing more predictable and reproducible outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 17, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged eighteen years or older

• Having a chronic wound (as defined by lack of at least 50% reduction in wound surface area over a period of four weeks)

• No clinical evidence of active wound bed infection

• No exposure of any vital structure (i.e., tendon, bone, vessel)

• Has signed the informed consent form prior to any study protocol related procedure

• Willing and able to adhere to protocol requirements

Exclusion Criteria:

• Any unstable medical condition that would cause the study treatment to be detrimental to the subject, as judged by the Principle Investigator

• Documented medical history of significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease would impede the subject's participation, as judged by the Principle Investigator

• Documented medical history of immunosuppression, immune deficiency disorder, or currently using immunosuppressive medications

• Having clinical presentation of active osteomyelitis

• Pregnancy or lactation

• Participation in another clinical study involving ulcers within thirty days prior to enrollment

Related Conditions & MeSH terms

• Chronic Venous Hypertension (Idiopathic) With Ulcer
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Wound Open
• Wounds and Injuries

Intervention

Device:
• Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement
Laser debridement entailed usage of an Er:YAG laser, employing the JOULE® machine (Sciton, Inc., Palo Alto, California). Full-field ablation was performed using the 2940 nm Er:YAG Contour TRL Resurfacing® application with the following settings: fluence - 50 J/cm2, spot overlap - 50%, pattern repeat - 0.5 seconds, spot size - 3-mm (Figure 1). Debridement was carried out until all fibrinous and/or necrotic tissues were removed, and healthy, bleeding tissue was visualized.

Procedure:
• Scalpel/Curette Debridement
Using a scalpel/curette, each patient's chronic wound is debrided until healthy, viable tissue is noted.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

References & Publications (17)

Alster TS, Lupton JR. Erbium:YAG cutaneous laser resurfacing. Dermatol Clin. 2001 Jul;19(3):453-66. Review. — View Citation

Bass LS. Erbium:YAG laser skin resurfacing: preliminary clinical evaluation. Ann Plast Surg. 1998 Apr;40(4):328-34. — View Citation

Brem H, Stojadinovic O, Diegelmann RF, Entero H, Lee B, Pastar I, Golinko M, Rosenberg H, Tomic-Canic M. Molecular markers in patients with chronic wounds to guide surgical debridement. Mol Med. 2007 Jan-Feb;13(1-2):30-9. — View Citation

Collins L, Seraj S. Diagnosis and treatment of venous ulcers. Am Fam Physician. 2010 Apr 15;81(8):989-96. — View Citation

Evison D, Brown RF, Rice P. The treatment of sulphur mustard burns with laser debridement. J Plast Reconstr Aesthet Surg. 2006;59(10):1087-93. Epub 2006 Jul 7. — View Citation

Falanga V. Chronic wounds: pathophysiologic and experimental considerations. J Invest Dermatol. 1993 May;100(5):721-5. Review. — View Citation

Graham JS, Schomacker KT, Glatter RD, Briscoe CM, Braue EH Jr, Squibb KS. Efficacy of laser debridement with autologous split-thickness skin grafting in promoting improved healing of deep cutaneous sulfur mustard burns. Burns. 2002 Dec;28(8):719-30. — View Citation

Hill KE, Davies CE, Wilson MJ, Stephens P, Harding KG, Thomas DW. Molecular analysis of the microflora in chronic venous leg ulceration. J Med Microbiol. 2003 Apr;52(Pt 4):365-369. doi: 10.1099/jmm.0.05030-0. — View Citation

Lam DG, Rice P, Brown RF. The treatment of Lewisite burns with laser debridement---'lasablation'. Burns. 2002 Feb;28(1):19-25. — View Citation

Palfreyman S. Assessing the impact of venous ulceration on quality of life. Nurs Times. 2008 Oct 14-20;104(41):34-7. — View Citation

Percival SL, Francolini I, Donelli G. Low-level laser therapy as an antimicrobial and antibiofilm technology and its relevance to wound healing. Future Microbiol. 2015;10(2):255-72. doi: 10.2217/fmb.14.109. Review. — View Citation

Pozner JN, Goldberg DJ. Superficial erbium:YAG laser resurfacing of photodamaged skin. J Cosmet Laser Ther. 2006 Jun;8(2):89-91. — View Citation

Reynolds N, Cawrse N, Burge T, Kenealy J. Debridement of a mixed partial and full thickness burn with an erbium:YAG laser. Burns. 2003 Mar;29(2):183-8. — View Citation

Roberts TL 3rd, Pozner JN. Lasers, facelifting, and the future. Clin Plast Surg. 2000 Apr;27(2):293-9. — View Citation

Stellar S, Meijer R, Walia S, Mamoun S. Carbon dioxide laser debridement of decubitus ulcers: followed by immediate rotation flap or skin graft closure. Ann Surg. 1974 Feb;179(2):230-7. — View Citation

Weinstein C, Pozner J, Scheflan M, Achauer BM. Combined Erbium:YAG Laser Resurfacing and Face Lifting. Plast Reconstr Surg. 2001 Feb;107(2):593-594. — View Citation

Weinstein C. Computerized scanning erbium:YAG laser for skin resurfacing. Dermatol Surg. 1998 Jan;24(1):83-9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain With Debridement	Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is used in our study to measure the intensity or frequency of pain. We have used Numerical Rating Scale (NRS), variant of VAS, which is a validated, uni-dimensional measure of pain intensity reported on an 11-point numeric scale. The scores were reported from "0" to "10," with "0" representative of "no pain," and "10" representative of the "worst possible pain".	Day 1 of the respective procedure (immediately following)
Primary	Bacterial Load Pre- and Post-Laser Debridement	Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. CFU = Colony Forming Units.	Day 1 of the laser procedure (immediately before and after)
Primary	Bacterial Load Pre- and Post-Sharp Debridement	Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement	Day 1 of the sharp procedure (immediately before and after)
Secondary	Patient Preference	Patient-reported preference of debridement type one week after study completion, reported as the count of participants that preferred either method.	2 weeks
Secondary	Percent Change in Wound Size- Immediately Post-debridement	The mean wound size increased immediately after debridement in both Groups, compared to the mean wound size before the debridement.	Day 1 of the respective procedure (immediately after)
Secondary	Percent Change in Wound Size - 1 Week Post-debridement	The mean percent change in wound size 1-week post-laser debridement was -20.8% ± 80.1%, as compared with -36.7% ± 54.3% 1-week post-sharp debridement (p = 0.6).	1 week following respective procedure