Burn ScarSMOOTHNCT04736251
Mechanistic Basis of Ablative Carbon Dioxide Laser in Treating Hypertrophic Scars
An observational study of Burn Scar and Scar, run by Naiem Moiemen at 1 site in United Kingdom.
Trial summary
This is an observational cohort study which will look at the biomarkers from blood and tissue sample for adult patients with hypertrophic scarring due to burns/trauma incident over 12 months from date of recruitment. Read more about this study
- Who is it for?
- Ages 16 years and older
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2019to 31 Aug 2023
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patient with hypertrophic scarring as a result of deep dermal or full thickness burns/trauma sustained more than 12 months prior to recruitment.
Who may be able to join
- Adult patients aged ≥ 16years
- Patient with hypertrophic scarring as a result of deep dermal or full thickness burns/trauma.
- Trauma or Burn sustained more than 12 months prior to recruitment.
- Treatment area to be ≥25cm2 confluent scarring with a comparable control scar on limb or trunk
- General Exclusion Criteria:
- Patients under 16 years of age
Show all 19Show fewer
- Previous laser therapy treatment to the study site
- The use of recent (within 6 months) or concurrent invasive scar treatments, including intra-lesional pharmaceuticals, micro needling or other laser modalities (e.g. Pulse-dye.)
- Known allergy or contraindication to EMLA™ 5% Cream (Lidocaine 2.5% and Prilocaine 2.5%), Dermol 500TM (Benzalkonium Chloride 0.1%; Chlorhexidine Dihydrochloride 0.1%; Liquid Paraffin 2.5%; Isopropyl Myristate 2.5%) or 50:50 ointment (White Soft Paraffin Liquid Paraffin %w/w 50 50.)
- Patients with Fitzpatrick skin type of 5-6 due to nature of the skin
- Laser Treatment Exclusion Criteria
- The presence of acute infection at the proposed treatment site
- Pregnancy or lactation
- Patients with poorly controlled Diabetes mellitus HbA1C >9% or 75mmol/mol within last 3 months)
- Patients experiencing acute exacerbation of Chronic skin diseases e.g. psoriasis or eczema
- Immunosuppression (HIV, drugs with immunosuppressive effect)
- Use of Roaccutane at any time within the last 6 months
- Autoimmune disorders in active stage (for example: 1. Localised; Type 1 Diabetes Mellitus, Addison's, Grave's and Crohn's Disease, 2. Systemic; Rheumatoid Arthritis, Multiple Sclerosis, Lups and Scleroderma).
- Known history of keloid scarring
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Minnie Ventura, MSc, 01213718220 ext. 18220, Maximina.Ventura@uhb.nhs.uk
Amy Bamford, RN, 01213718226 ext. 18226, Amy.Bamford@uhb.nhs.uk
About this study
Official title: A Prospective Intra-patient Single-blinded Randomised Trial to Examine the Mechanistic Basis of fractiOnal Ablative carbOn Dioxide Laser Therapy in Treating Adult Burns and/or Trauma Patients With Hypertrophic Scarring
This is an observational cohort study which will look at the biomarkers from blood and tissue sample for adult patients with hypertrophic scarring due to burns/trauma incident over 12 months from date of recruitment. The study will assess the kinetics of the response to fractionated carbon dioxide laser therapy in hypertrophic scars.
Read the detailed description
Research has identified a gap in the knowledge of how fractional ablative carbon dioxide laser works on hypertrophic (thickened) scars. At present there is no accurate measure of how effective the benefit is objectively (medically), subjectively (to the patient) and histologically (on a microscopic level). Recent systematic review has shown an improvement in scars following laser therapy, however it found the quality of the data to be poor, confounded by multiple bias, identifying the lack of evidence to prove the worth and effectiveness of lasers. It concluded the need for more robust studies.
The study plans to observe a group of patients with hypertrophic burn and/or trauma scars (over 1 year old) and see what happens to their scars using the fractionated carbon dioxide laser therapy. Two similar scars will be identified per patient volunteer and will randomly allocate to receive either fractionated carbon dioxide laser therapy or standard care. An independent assessor will be blinded to the intervention and control scar sites.
The trial will aim to identify any biological markers found in participants blood and scar tissue and if they change through the course of and following laser therapy. This will help with understanding the mechanism of how the carbon dioxide laser works on scars.
As part of the evaluation of the impact of laser treatment on patients' quality of life, a patient reported outcome measures (PROMS) validation study will be carried out. PROMs describe how the patient is functioning or feeling without input from clinical staff providing a unique perspective of patients' lived experience of the disease as not all symptoms or impacts are obvious to clinicians. In order for PROMs to be effective in clinical trials and practice, they have to capture information on domains that matter to the patient. These include: scarring, movement and function, scar sensation, psychological distress, body image and confidence, engagement in activities, treatment burden and impact on relationships.
The scars will be assessed in a number of different ways; scar assessment tools/questionnaires, clinical inspection, photography, use of ultrasound, probes with suction to test the elasticity and pliability of the scars and the colour, microscopic evaluation and the identification of biomarkers from blood samples and scar and normal tissue biopsy.
- Medical subject headings
- Cicatrix
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the number of senescent cells and the sub-population of fibroblasts 12 months after the last CO2 laser therapy
Measuring the proportion of senescent cells and the proportion and sub-population of fibroblasts following treatment to determine positive effect of CO2 laser therapy through histological assessment. In particular, to assess:
- Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 3 weeks after 1st laser treatment.
- Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 3 months after 1st laser treatment.
- Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 6 months after 1st laser treatment.
- Changes in the protortion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 18 months after 1st laser treatment.
Measured: 18 months
Secondary outcomes (9)
Vancouver Scar Scale
This scale uses a numerical assessment of four skin characteristics including: Height (range, 0-4), Pliability (range, 0-4), Vascularity (range, 0-3), and Pigmentation (range, 0-3). The assessors choose a numerical value for each of these characteristics based on a comparison with normal skin.
Measured: 18 months
Patient and Observer Scar Assessment Scale (POSAS)
POSAS questionnaire seeks to measure scar quality. POSAS, version 2.0 is a subjective scar scale that consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale and together they make up the 'Total Score' of the Patient and Observer Scale.
The POSAS Observer scale assesses the scar in terms of vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion.
The POSAS Patient scale assesses the scar in terms of pain, itching, scar colour, stiffness, thickness and irregularity, and overall opinion.
Measured: 18 months
Brisbane Burn Scar Impact Profile (BBSIP)
The Brisbane Burn Scar Impact Profile (BBSIP, version 1.0) is a questionnaire that was developed to assess the health-related quality of life in people with burn scars. It consists of seven parts which measure the overall impact of burn scars; itch, pain and other sensations (and their impact on the subject); impact of the burn scars on work and daily activities; impact of the burn scars on relationships and social interactions; subjects perception of the impact of the burn scars on their appearance; their emotional reactions towards their scars; and physical symptoms caused by the burn scars.
Measured: 18 months
Health status
The EQ-5D is a questionnaire used for measuring generic health status. The EQ-5D questionnaire consists of 5 questions relating to different domains of quality of life (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) for each of which there are 3 levels of response (no problems, some problems or severe problems).
Measured: 18 months
Quantify scar colour
The DSM III Colormeter (Cortex Technology) combines two methods of quantifying colour: narrow-band spectrophotometry (melanin, erythema) and tristimulus reflectance colorimetry in a single measurement. It has a skin measuring area of .7mm in diameter.
Measured: 18 months
Quantify scar thickness
The Dermascan C USB (Cortex Technology) is a high-frequency (20MHz) ultrasound scanner that enables the imaging of soft tissue at high resolution with a computer, and comes with software that allows automated skin thickness measurement. A medium focus transducer will be used with a 12mm wide viewing field and penetration depth of 15mm. All measurements are to be performed with an ultrasound frequency set at 1580m/s. Thickness and density (as a measure of total intensity in percentage) measurements are then generated using the dedicated software (Advance Control 6 Analysis SW package, Cortex).
The thickness measured is defined as the distance between the echogenic stratum corneum and the inner surface of the dermis (in millimetres).
Measured: 18 months
Quantify scar elasticity
The cutometer (MPA 580, Courage and Khazaka) is an electronic instrument that assesses skin elasticity. The probe of the device is placed over the area of measurement, and then generates a negative pressure which draws the skin into a hollow aperture in the centre of the probe and then uses a laser to estimate the amount of skin displacement.
The probe with a 6-mm diameter hollow aperture was chosen for this study as previous studies have determined it to be the most efficient size to measure the visco-elasticity properties of the dermis. For this study, mode 1 was chosen. This delivers three cycles of negative air pressure (500 mbar) for 2 seconds, followed by 2 seconds of no pressure. Results are expressed as the means of the three measurement cycles.
Measured: 18 months
Quantify scar volume
The Vectra H1 handheld imaging system delivers high resolution 3D images for clinical use. Three-dimensional (3D) measurement systems are used to overcome the limitation of 2D photograph, mostly used for clinical documentation. They can be utilised to measure surface area of wounds, but additionally be able to measure the volume of scars much more quickly and easily compared to traditional methods such as moulding. The study will measure the volume of scar in cubic centimetre.
Measured: 18 months
Novel markers associated with scar formation, wound healing and variables of scar behaviours in response to CO2 laser therapy
The following will be assessed:
- The percentage expression of TGF-beta at time points on day1, 3 weeks, 3 months 6 months and 18 months.
- The percentage expression of PDGF at time points on day1, 3 weeks, 3 months 6 months and 18 months.
- The percentage expression of Decorin (%) at time points on day1, 3 weeks, 3 months 6 months and 18 months.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start9 Dec 2019
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Burn ScarStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naiem Moiemen
- Sponsor type
- University, hospital or other
- Collaborators
- The Scar Free Foundation Centre for Conflict Wound Research, University of Birmingham, Welsh Centre for Burns and Plastic Surgery, Morriston Hospital
- Responsible party
- Sponsor-investigator, Naiem Moiemen, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Naiem Moiemen, GMC, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736251
- Sponsor's protocol ID
- RRK6716
- Acronym
- SMOOTH
- Status last verified
- Nov 2021
- First submitted
- 27 Oct 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gangemi EN, Gregori D, Berchialla P, Zingarelli E, Cairo M, Bollero D, Ganem J, Capocelli R, Cuccuru F, Cassano P, Risso D, Stella M. Epidemiology and risk factors for pathologic scarring after burn wounds. Arch Facial Plast Surg. 2008 Mar-Apr;10(2):93-102. doi: 10.1001/archfaci.10.2.93.
PubMed 18347236Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
PubMed 15216537Zuccaro J, Ziolkowski N, Fish J. A Systematic Review of the Effectiveness of Laser Therapy for Hypertrophic Burn Scars. Clin Plast Surg. 2017 Oct;44(4):767-779. doi: 10.1016/j.cps.2017.05.008. Epub 2017 Jul 10.
PubMed 28888302Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG. Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5.
PubMed 20927486Slemp AE, Kirschner RE. Keloids and scars: a review of keloids and scars, their pathogenesis, risk factors, and management. Curr Opin Pediatr. 2006 Aug;18(4):396-402. doi: 10.1097/01.mop.0000236389.41462.ef.
PubMed 16914994Shaw AC, Joshi S, Greenwood H, Panda A, Lord JM. Aging of the innate immune system. Curr Opin Immunol. 2010 Aug;22(4):507-13. doi: 10.1016/j.coi.2010.05.003.
PubMed 20667703Gunin AG, Kornilova NK, Petrov VV, Vasil'eva OV. [Age-related changes in the number and proliferation of fibroblasts in the human skin]. Adv Gerontol. 2011;24(1):43-7. Russian.
PubMed 21809619Coppe JP, Desprez PY, Krtolica A, Campisi J. The senescence-associated secretory phenotype: the dark side of tumor suppression. Annu Rev Pathol. 2010;5:99-118. doi: 10.1146/annurev-pathol-121808-102144.
PubMed 20078217Demaria M, Ohtani N, Youssef SA, Rodier F, Toussaint W, Mitchell JR, Laberge RM, Vijg J, Van Steeg H, Dolle ME, Hoeijmakers JH, de Bruin A, Hara E, Campisi J. An essential role for senescent cells in optimal wound healing through secretion of PDGF-AA. Dev Cell. 2014 Dec 22;31(6):722-33. doi: 10.1016/j.devcel.2014.11.012. Epub 2014 Dec 11.
PubMed 25499914Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184Tyack Z, Kimble R, McPhail S, Plaza A, Simons M. Psychometric properties of the Brisbane Burn Scar Impact Profile in adults with burn scars. PLoS One. 2017 Sep 13;12(9):e0184452. doi: 10.1371/journal.pone.0184452. eCollection 2017.
PubMed 28902874Griffiths C, Guest E, White P, Gaskin E, Rumsey N, Pleat J, Harcourt D. A Systematic Review of Patient-Reported Outcome Measures Used in Adult Burn Research. J Burn Care Res. 2017 Mar/Apr;38(2):e521-e545. doi: 10.1097/BCR.0000000000000474.
PubMed 27893571Jones LL, Calvert M, Moiemen N, Deeks JJ, Bishop J, Kinghorn P, Mathers J; PEGASUS team. Outcomes important to burns patients during scar management and how they compare to the concepts captured in burn-specific patient reported outcome measures. Burns. 2017 Dec;43(8):1682-1692. doi: 10.1016/j.burns.2017.09.004. Epub 2017 Oct 12.
PubMed 29031889Andrews N, Jones LL, Moiemen N, Calvert M, Kinghorn P, Litchfield I, Bishop J, Deeks JJ, Mathers J; PEGASUS Study Group. Below the surface: Parents' views on the factors that influence treatment adherence in paediatric burn scar management - A qualitative study. Burns. 2018 May;44(3):626-635. doi: 10.1016/j.burns.2017.09.003. Epub 2017 Oct 12.
PubMed 29031888Lee KC, Dretzke J, Grover L, Logan A, Moiemen N. A systematic review of objective burn scar measurements. Burns Trauma. 2016 Apr 27;4:14. doi: 10.1186/s41038-016-0036-x. eCollection 2016.
PubMed 27574684
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Intra-patient Single-blinded Randomised Trial to Examine the Mechanistic Basis of fractiOnal Ablative carbOn Dioxide Laser Therapy in Treating Adult Burns and/or Trauma Patients With Hypertrophic Scarring
- ClinicalTrials.gov ID
- NCT04736251
- Acronym / sponsor ID
- SMOOTH / RRK6716
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Naiem MoiemenUniversity, hospital or other
- Collaborators
- The Scar Free Foundation Centre for Conflict Wound Research, University of Birmingham, Welsh Centre for Burns and Plastic Surgery, Morriston Hospital
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 3 Feb 2021 (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.
This is an observational cohort study which will look at the biomarkers from blood and tissue sample for adult patients with hypertrophic scarring due to burns/trauma incident over 12 months from date of recruitment. The study will assess the kinetics of the response to fractionated carbon dioxide laser therapy in hypertrophic scars.
Detailed description
Research has identified a gap in the knowledge of how fractional ablative carbon dioxide laser works on hypertrophic (thickened) scars. At present there is no accurate measure of how effective the benefit is objectively (medically), subjectively (to the patient) and histologically (on a microscopic level). Recent systematic review has shown an improvement in scars following laser therapy, however it found the quality of the data to be poor, confounded by multiple bias, identifying the lack of evidence to prove the worth and effectiveness of lasers. It concluded the need for more robust studies.
The study plans to observe a group of patients with hypertrophic burn and/or trauma scars (over 1 year old) and see what happens to their scars using the fractionated carbon dioxide laser therapy. Two similar scars will be identified per patient volunteer and will randomly allocate to receive either fractionated carbon dioxide laser therapy or standard care. An independent assessor will be blinded to the intervention and control scar sites.
The trial will aim to identify any biological markers found in participants blood and scar tissue and if they change through the course of and following laser therapy. This will help with understanding the mechanism of how the carbon dioxide laser works on scars.
As part of the evaluation of the impact of laser treatment on patients' quality of life, a patient reported outcome measures (PROMS) validation study will be carried out. PROMs describe how the patient is functioning or feeling without input from clinical staff providing a unique perspective of patients' lived experience of the disease as not all symptoms or impacts are obvious to clinicians. In order for PROMs to be effective in clinical trials and practice, they have to capture information on domains that matter to the patient. These include: scarring, movement and function, scar sensation, psychological distress, body image and confidence, engagement in activities, treatment burden and impact on relationships.
The scars will be assessed in a number of different ways; scar assessment tools/questionnaires, clinical inspection, photography, use of ultrasound, probes with suction to test the elasticity and pliability of the scars and the colour, microscopic evaluation and the identification of biomarkers from blood samples and scar and normal tissue biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patient with hypertrophic scarring as a result of deep dermal or full thickness burns/trauma sustained more than 12 months prior to recruitment.
Key inclusion criteria (19 listed)
- Adult patients aged ≥ 16years
- Patient with hypertrophic scarring as a result of deep dermal or full thickness burns/trauma.
- Trauma or Burn sustained more than 12 months prior to recruitment.
- Treatment area to be ≥25cm2 confluent scarring with a comparable control scar on limb or trunk
- Patients under 16 years of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect the number of senescent cells and the sub-population of fibroblasts 12 months after the last CO2 laser therapy
Time frame: 18 months
Measuring the proportion of senescent cells and the proportion and sub-population of fibroblasts following treatment to determine positive effect of CO2 laser therapy through histological assessment. In particular, to assess: 1. Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 3 weeks after 1st laser treatment. 2. Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 3 months after 1st laser treatment. 3. Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 6 months after 1st laser treatment. 4. Changes in the protortion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 18 months after 1st laser treatment.
9 secondary outcomes
Vancouver Scar Scale
Time frame: 18 months
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 18 months
Brisbane Burn Scar Impact Profile (BBSIP)
Time frame: 18 months
Health status
Time frame: 18 months
Quantify scar colour
Time frame: 18 months
Quantify scar thickness
Time frame: 18 months
Quantify scar elasticity
Time frame: 18 months
Quantify scar volume
Time frame: 18 months
Novel markers associated with scar formation, wound healing and variables of scar behaviours in response to CO2 laser therapy
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Background: PubMed 18347236Gangemi EN, Gregori D, Berchialla P, Zingarelli E, Cairo M, Bollero D, Ganem J, Capocelli R, Cuccuru F, Cassano P, Risso D, Stella M. Epidemiology and risk factors for pathologic scarring after burn wounds. Arch Facial Plast Surg. 2008 Mar-Apr;10(2):93-102. doi: 10.1001/archfaci.10.2.93.
- Background: PubMed 15216537Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
- Background: PubMed 28888302Zuccaro J, Ziolkowski N, Fish J. A Systematic Review of the Effectiveness of Laser Therapy for Hypertrophic Burn Scars. Clin Plast Surg. 2017 Oct;44(4):767-779. doi: 10.1016/j.cps.2017.05.008. Epub 2017 Jul 10.
- Background: PubMed 20927486Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG. Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5.
- Background: PubMed 16914994Slemp AE, Kirschner RE. Keloids and scars: a review of keloids and scars, their pathogenesis, risk factors, and management. Curr Opin Pediatr. 2006 Aug;18(4):396-402. doi: 10.1097/01.mop.0000236389.41462.ef.
- Background: PubMed 20667703Shaw AC, Joshi S, Greenwood H, Panda A, Lord JM. Aging of the innate immune system. Curr Opin Immunol. 2010 Aug;22(4):507-13. doi: 10.1016/j.coi.2010.05.003.
- Background: PubMed 21809619Gunin AG, Kornilova NK, Petrov VV, Vasil'eva OV. [Age-related changes in the number and proliferation of fibroblasts in the human skin]. Adv Gerontol. 2011;24(1):43-7. Russian.
- Background: PubMed 20078217Coppe JP, Desprez PY, Krtolica A, Campisi J. The senescence-associated secretory phenotype: the dark side of tumor suppression. Annu Rev Pathol. 2010;5:99-118. doi: 10.1146/annurev-pathol-121808-102144.
- Background: PubMed 25499914Demaria M, Ohtani N, Youssef SA, Rodier F, Toussaint W, Mitchell JR, Laberge RM, Vijg J, Van Steeg H, Dolle ME, Hoeijmakers JH, de Bruin A, Hara E, Campisi J. An essential role for senescent cells in optimal wound healing through secretion of PDGF-AA. Dev Cell. 2014 Dec 22;31(6):722-33. doi: 10.1016/j.devcel.2014.11.012. Epub 2014 Dec 11.
- Background: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Background: PubMed 28902874Tyack Z, Kimble R, McPhail S, Plaza A, Simons M. Psychometric properties of the Brisbane Burn Scar Impact Profile in adults with burn scars. PLoS One. 2017 Sep 13;12(9):e0184452. doi: 10.1371/journal.pone.0184452. eCollection 2017.
- Background: PubMed 27893571Griffiths C, Guest E, White P, Gaskin E, Rumsey N, Pleat J, Harcourt D. A Systematic Review of Patient-Reported Outcome Measures Used in Adult Burn Research. J Burn Care Res. 2017 Mar/Apr;38(2):e521-e545. doi: 10.1097/BCR.0000000000000474.
- Individual participant dataSharing planned: No
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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.
Naiem Moiemen, GMC principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Scar and Scar, run by Naiem Moiemen at 1 site in United Kingdom.
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 19 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 Nov 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minnie Ventura, MSc (01213718220 ext. 18220, Maximina.Ventura@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the number of senescent cells and the sub-population of fibroblasts 12 months after the last CO2 laser therapy (time frame: 18 months). 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 NCT04736251, which also lists 22 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 8 Nov 2021.