Wound OpenNCT03182582
Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds
A study testing Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement and Scalpel/Curette Debridement in people with Wound Open and Chronic Venous Hypertension (Idiopathic) With Ulcer, run by Stanford University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement and Scalpel/Curette Debridement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 17 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Efficacy of the Er:YAG Laser Debridement on Patient-Reported Pain and Bacterial Load in Chronic Wounds
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.
Read the detailed 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.
- Being tested
- Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement, Scalpel/Curette Debridement
- Keywords
- Laser Debridement, Debridement
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser DebridementDevice
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.
Scalpel/Curette DebridementProcedure or surgery
Using a scalpel/curette, each patient's chronic wound is debrided until healthy, viable tissue is noted.
| Study group | Role | What they receive |
|---|---|---|
| Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement | Active comparator | During the first treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. During the second treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.
Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.
Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment. Receives: Device: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement; Procedure: Scalpel/Curette Debridement |
| Week 1 - Scalpel/Curette Debridement | Active comparator | During the first treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. During the second treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized.
Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.
Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment. Receives: Device: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement; Procedure: Scalpel/Curette Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Day 1 of the respective procedure (immediately following)
Bacterial Load Pre- and Post-Laser Debridement
Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. CFU = Colony Forming Units.
Measured: Day 1 of the laser procedure (immediately before and after)
Bacterial Load Pre- and Post-Sharp Debridement
Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement
Measured: Day 1 of the sharp procedure (immediately before and after)
Secondary outcomes (3)
Patient Preference
Patient-reported preference of debridement type one week after study completion, reported as the count of participants that preferred either method.
Measured: 2 weeks
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.
Measured: Day 1 of the respective procedure (immediately after)
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).
Measured: 1 week following respective procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start5 Jan 2017
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Wound OpenStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- A portion of the patients will be randomized to sharp debridement first, then laser for the second debridement. The other portion will undergo this in the opposite order.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey C. Gurtner, Stanford University
- Investigators
- Shannon Meyer, CCRC, Study director, Clinical Trial Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182582
- Sponsor's protocol ID
- IRB-35141
- Status last verified
- Mar 2020
- First submitted
- 31 May 2017
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12676877Collins L, Seraj S. Diagnosis and treatment of venous ulcers. Am Fam Physician. 2010 Apr 15;81(8):989-96.
PubMed 20387775Palfreyman S. Assessing the impact of venous ulceration on quality of life. Nurs Times. 2008 Oct 14-20;104(41):34-7.
PubMed 18979958Falanga V. Chronic wounds: pathophysiologic and experimental considerations. J Invest Dermatol. 1993 May;100(5):721-5. doi: 10.1111/1523-1747.ep12472373. No abstract available.
PubMed 8491995Brem 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. doi: 10.2119/2006-00054.Brem.
PubMed 17515955Percival 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.
PubMed 25689537Evison D, Brown RF, Rice P. The treatment of sulphur mustard burns with laser debridement. J Plast Reconstr Aesthet Surg. 2006;59(10):1087-93. doi: 10.1016/j.bjps.2006.02.010. Epub 2006 Jul 7.
PubMed 16996434Graham 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. doi: 10.1016/s0305-4179(02)00198-5.
PubMed 12464469Lam DG, Rice P, Brown RF. The treatment of Lewisite burns with laser debridement---'lasablation'. Burns. 2002 Feb;28(1):19-25. doi: 10.1016/s0305-4179(01)00078-x.
PubMed 11834325Reynolds 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. doi: 10.1016/s0305-4179(02)00247-4. No abstract available.
PubMed 12615469Stellar 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. doi: 10.1097/00000658-197402000-00022. No abstract available.
PubMed 4590105Alster TS, Lupton JR. Erbium:YAG cutaneous laser resurfacing. Dermatol Clin. 2001 Jul;19(3):453-66. doi: 10.1016/s0733-8635(05)70286-2.
PubMed 11599402Pozner JN, Goldberg DJ. Superficial erbium:YAG laser resurfacing of photodamaged skin. J Cosmet Laser Ther. 2006 Jun;8(2):89-91. doi: 10.1080/14764170600717852.
PubMed 16766487Bass LS. Erbium:YAG laser skin resurfacing: preliminary clinical evaluation. Ann Plast Surg. 1998 Apr;40(4):328-34. doi: 10.1097/00000637-199804000-00002.
PubMed 9555984Weinstein C. Computerized scanning erbium:YAG laser for skin resurfacing. Dermatol Surg. 1998 Jan;24(1):83-9. doi: 10.1111/j.1524-4725.1998.tb04058.x.
PubMed 9464295
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Er:YAG Laser Debridement on Patient-Reported Pain and Bacterial Load in Chronic Wounds
- ClinicalTrials.gov ID
- NCT03182582
- Acronym / sponsor ID
- IRB-35141
- Keywords
- Laser Debridement, Debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A portion of the patients will be randomized to sharp debridement first, then laser for the second debridement. The other portion will undergo this in the opposite order.
| Arm | Type | Receives |
|---|---|---|
| Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement | Active comparator | Device: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement, Procedure: Scalpel/Curette DebridementDuring the first treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. During the second treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing. Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment. |
| Week 1 - Scalpel/Curette Debridement | Active comparator | Device: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement, Procedure: Scalpel/Curette DebridementDuring the first treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. During the second treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing. Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser DebridementLaser 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. | Device | Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement, Week 1 - Scalpel/Curette Debridement |
| Scalpel/Curette DebridementUsing a scalpel/curette, each patient's chronic wound is debrided until healthy, viable tissue is noted. | Procedure or surgery | Week 1 - Erbium:Yttrium-Aluminum-Garnet Laser Debridement, Week 1 - Scalpel/Curette Debridement |
Primary outcome
Pain With Debridement
Time frame: Day 1 of the respective procedure (immediately following)
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".
Bacterial Load Pre- and Post-Laser Debridement
Time frame: Day 1 of the laser procedure (immediately before and after)
Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. CFU = Colony Forming Units.
Bacterial Load Pre- and Post-Sharp Debridement
Time frame: Day 1 of the sharp procedure (immediately before and after)
Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement
3 secondary outcomes
Patient Preference
Time frame: 2 weeks
Percent Change in Wound Size- Immediately Post-debridement
Time frame: Day 1 of the respective procedure (immediately after)
Percent Change in Wound Size - 1 Week Post-debridement
Time frame: 1 week following respective procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12676877Hill 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.
- Background: PubMed 20387775Collins L, Seraj S. Diagnosis and treatment of venous ulcers. Am Fam Physician. 2010 Apr 15;81(8):989-96.
- Background: PubMed 18979958Palfreyman S. Assessing the impact of venous ulceration on quality of life. Nurs Times. 2008 Oct 14-20;104(41):34-7.
- Background: PubMed 8491995Falanga V. Chronic wounds: pathophysiologic and experimental considerations. J Invest Dermatol. 1993 May;100(5):721-5. doi: 10.1111/1523-1747.ep12472373. No abstract available.
- Background: PubMed 17515955Brem 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. doi: 10.2119/2006-00054.Brem.
- Background: PubMed 25689537Percival 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.
- Background: PubMed 16996434Evison D, Brown RF, Rice P. The treatment of sulphur mustard burns with laser debridement. J Plast Reconstr Aesthet Surg. 2006;59(10):1087-93. doi: 10.1016/j.bjps.2006.02.010. Epub 2006 Jul 7.
- Background: PubMed 12464469Graham 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. doi: 10.1016/s0305-4179(02)00198-5.
- Background: PubMed 11834325Lam DG, Rice P, Brown RF. The treatment of Lewisite burns with laser debridement---'lasablation'. Burns. 2002 Feb;28(1):19-25. doi: 10.1016/s0305-4179(01)00078-x.
- Background: PubMed 12615469Reynolds 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. doi: 10.1016/s0305-4179(02)00247-4. No abstract available.
- Background: PubMed 4590105Stellar 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. doi: 10.1097/00000658-197402000-00022. No abstract available.
- Background: PubMed 11599402Alster TS, Lupton JR. Erbium:YAG cutaneous laser resurfacing. Dermatol Clin. 2001 Jul;19(3):453-66. doi: 10.1016/s0733-8635(05)70286-2.
- Individual participant dataSharing planned: No
Related trials for Wound Open
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
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.
Shannon Meyer, CCRC study director
Clinical Trial Coordinator
Questions about this trial
What is this clinical trial studying?
A study testing Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement and Scalpel/Curette Debridement in people with Wound Open and Chronic Venous Hypertension (Idiopathic) With Ulcer, run by Stanford University.
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 6 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain With Debridement (time frame: Day 1 of the respective procedure (immediately following)). The study lists 3 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 NCT03182582, which also lists 17 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 30 Mar 2020.