Second Degree BurnsNCT02497326
Heparin for the Treatment of Burn Wound Pain
A study testing Polyfax & Lignocain gel or silvazine cream, Topical Heparin and Tramadol in people with Second Degree Burns, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Pain Associated with partial thickness burns (PTB) is very severe and distressing for the patients.Topical conventional treatment of superficial PTB wounds includes application of polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are treated with silvazine cream twice a day and… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Second Degree Burns
- What is being tested?
- Polyfax & Lignocain gel or silvazine cream, Topical Heparin and Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Either gender with age limits 14-60 years.
- 2nd degree burn with Total burn surface area (TBSA) <20% (assessed by Wallace rule of nine) including front of chest and abdomen, upper limbs excluding hands and lower limbs excluding foot.
- Flame and scald burn (on history).
Who cannot join
- Third degree (painless, lathery eschar with no blanching) and Fourth degree burns (full thickness burn with exposed muscle, tendons or bones) as assessed clinically.
- Chemical or electrical burn (on history).
- Personal or family history of hemorrhagic diathesis, heparin intolerance, any medical illness causing bleeding episodes(e.g, Esophageal varices) or active bleeding from any site.
- History of Liver disease (Total Bilirubin <20umol/L, Alanine amino transferase <36u/L, Aspartate amino transferase <42u/L), or renal disorder (Serum Urea=20-40mg/dl, Serum Creatinine <1.2).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Plastic Surgery, Mayo Hospital, King Edward Medical University
Lahore, Punjab Province, 54000
Muhammad M Bashir, F.C.P.S, 923336517745, mmbashir1@gmail.com
Sobia Manzoor, M.B.B.S, +923344094072, drsobiamanzoor@yahoo.com
About this study
Official title: Comparative Study of Conventional and Topical Heparin Treatments in Second Degree Burn Patients for Burn Analgesia and Duration of Wound Healing
Pain Associated with partial thickness burns (PTB) is very severe and distressing for the patients.Topical conventional treatment of superficial PTB wounds includes application of polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are treated with silvazine cream twice a day and prepared for grafting if not healed within 3 weeks. Existing conventional therapy is un-comfortable and expensive for the patients. Search continues for a reliable, safe, cheap and effective treatment of burn.Topical use of heparin has been found effective in reducing pain associated with burn wounds. More over use of heparin topically in burn patients is easy to perform and cheap but at the moment, evidence of its effectiveness is weak. Current study is being conducted to verify clinical effectiveness of use of heparin in 2nd degree burns by comparing it with topical conventional treatment.
Read the detailed description
Second degree or partial thickness burn (PTB) is most tricky variety to identify and treat, out of all four categories of burn (based on depth). It is further divided into superficial and deep partial thickness based on the depth of dermal injury. (1) Clinical criteria fulfilling all the points for each category i.e. Superficial PTB (SPTB) being reddish pink, bleed briskly (in <3sec) on pin prick, blanch with brisk return (in <2 sec) on pressure, blister formation and Deep PTB (DPTB) being mottled pink, delayed bleeding (in >3 sec) on pin prick, slow return (in >2 sec) on pressure, no blister, is most commonly used to differentiate both the sub-classes. Pain is hallmark of 2nd degree burns and is treated by topical and IV analgesics. Topical conventional treatment of superficial PTB wounds includes application of polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are treated with silvazine cream twice a day and prepared for grafting by normal saline dressings, if not healed within 3 weeks.
Current treatment for 2nd degree burn is complex, uncomfortable for the patient and expensive for the health systems (2,3) . Search continues for a reliable, safe, cheap and effective treatment of burn. Heparin has been used topically in burn patient and a protocol of topical heparin use has been introduced . It is believed that heparin helps in reducing pain associated with burns and duration of wound healing. (4) It is noted that the mechanism involved in heparin's action on the burn probably derives from its anti-inflammatory and angiogenic properties, stimulating tissue repair and re-epithelializing effects.(2) These actions do not depend on its well-known anticoagulant action. Burn analgesia by heparin is caused by inhibition of pro-inflammatory products which act on free nerve endings and cause pain. In this regard, isolated case reports continue to emerge, suggesting that heparin is able to promote tissue repair and inhibit inflammation in burn patients.(5) It has been shown in a study that out of total 58 patients, those in topical Heparin group demanded less analgesic medications in mg/day (11.83 ± 9.38) than Control group (33.35± 20.63) . It has been reported in another study that heparin applied topically for 5 days in 50 pediatric patients reduced healing time. (6) Indeed there are a number of reports of heparin being used, topically or systemically but there is a lack of effectively controlled studies in this area for clear conclusions to be drawn as to the efficacy of this approach.(7) As it is noted that already existing conventional therapy is un-comfortable and expensive for the patients, use of heparin topically in burn patients is easy to perform and cheap but at the moment, evidence of its effectiveness is weak. So rationale of the study is to verify clinical effectiveness of use of heparin in 2nd degree burns.
Objective:- To compare conventional treatment and topical heparin treatment in 2nd degree burn patients in terms of total consumption of analgesic medication and duration of wound healing.
- Conditions
- Second Degree Burns
- Being tested
- Polyfax & Lignocain gel or silvazine cream, Topical Heparin, Tramadol
- Keywords
- second degree burns, heparin, topical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyfax & Lignocain gel or silvazine creamDrug
olyfax skin ointment plus Lignocain gel will be applied on superficial PTB area and silver sulphadiazine cream on deep PTB in morning and evening after wound wash.
Topical HeparinDrug
Heparin solution (5000 IU/ml) will be sprinkled aseptically on burn surface twice a day for the first 2 days, by "#27" needle connected via drip set to the drip containing heparin aqueous saline. The dose will be reduced to 75% of day 1 on day 3 and 4 and to 50% on day 5. Administration of heparin saline solution will be in 3 cycles with 5-10 minutes interval
TramadolDrug
IV Analgesic ( Inj. Tramadol 10mg/dose) will only be given to the patients (in both groups) having pain score >4, assessed 3 times a day by Numeric Visual Analogue scale (NVAS).
| Study group | Role | What they receive |
|---|---|---|
| Polyfax & Lignocain gel or silvazine cream | Active comparator | Polyfax skin ointment plus Lignocain gel will be applied on superficial PTB area and silver sulphadiazine cream on deep PTB in morning and evening after wound wash Receives: Drug: Polyfax & Lignocain gel or silvazine cream; Drug: Tramadol |
| Topical heparin | Experimental | Heparin solution (5000 IU/ml) will be sprinkled aseptically on burn surface twice a day for the first 2 days, by "#27" needle connected via drip set to the drip containing heparin aqueous saline. The dose will be reduced to 75% of day 1 on day 3 and 4 and to 50% on day 5. Administration of heparin saline solution will be in 3 cycles with 5-10 minutes interval. Receives: Drug: Topical Heparin; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of Analgesic Medication
Total consumption of Analgesic Medication will be calculated as total of the amount of IV analgesics required (mg/day) by patient, for the first 5 days of treatment, taking day of admission as "day 0". IV Analgesic ( Inj. Tramadol 10mg/dose) will only be given to the patients having pain score >4, assessed 3 times a day by Numeric Visual Analogue scale (NVAS).
Measured: 5 days
Duration of wound healing
Duration of Wound Healing in SPTB will be assessed by
- Noting down the days required for the wound to re-epithelialize ≥70% . The number of day when ≥70% re-epithelialization has occured in SPTB will be noted taking day of starting treatment as 'day zero'
Measured: From date of staring treatment until the date when ≥70% re-epithelialization of SPTB has occured upto 21 days
Duration of wound healing
Duration of Wound Healing in DPTB will be assessed by noting down days required for the wound to be ready for grafting in taking day 21 after staring treatment as "day 0" Wound will said to be ready for skin grafting if completely (100%) covered by granulation tissue with epithelialized margins.
Measured: Date on Twenty first day after starting treatment untill the date when DPTB ready for skin grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Second Degree BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mustehsan Bashir, King Edward Medical University
- Investigators
- Muhammad M Bashir, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497326
- Sponsor's protocol ID
- 84/RC/KEMU
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
Publications
Klein MB. Thermal,chemical and electrical injuries In:Thorne CH et al.(ed.)Grabb and Smith's plastic surgery.7th ed. Philadelphia,Lippincott Williams & Wilkins;2014. p128 - 129. ISBN 978-1-4511-0955-9.
Barretto MG, Costa Mda G, Serra MC, Afiune JB, Praxedes HE, Pagani E. [Comparative study of conventional and topical heparin treatments for burns analgesia]. Rev Assoc Med Bras (1992). 2010 Jan-Feb;56(1):51-5. doi: 10.1590/s0104-42302010000100016. Portuguese.
PubMed 20339787Klein MB, Hollingworth W, Rivara FP, Kramer CB, Askay SW, Heimbach DM, Gibran NS. Hospital costs associated with pediatric burn injury. J Burn Care Res. 2008 Jul-Aug;29(4):632-7. doi: 10.1097/BCR.0b013e31817db951.
PubMed 18535469Saliba MJ Jr. Heparin in the treatment of burns 2011". http://www.salibaburnsinstitute.org/ PROTOCOL.html.
Ferreira Chacon JM, Mello de Andrea ML, Blanes L, Ferreira LM. Effects of topical application of 10,000 IU heparin on patients with perineal dermatitis and second-degree burns treated in a public pediatric hospital. J Tissue Viability. 2010 Nov;19(4):150-8. doi: 10.1016/j.jtv.2010.03.003. Epub 2010 Apr 20.
PubMed 20409713Venkatachalapathy TS. A comparative study of paediatric thermal burns treated with topical heparin and without heparin. Indian J Surg. 2014 Aug;76(4):282-7. doi: 10.1007/s12262-012-0674-6. Epub 2012 Oct 5.
PubMed 25278651Oremus M, Hanson MD, Whitlock R, Young E, Archer C, Dal Cin A, Gupta A, Raina P. A systematic review of heparin to treat burn injury. J Burn Care Res. 2007 Nov-Dec;28(6):794-804. doi: 10.1097/BCR.0b013e3181599b9b.
PubMed 17925636
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Conventional and Topical Heparin Treatments in Second Degree Burn Patients for Burn Analgesia and Duration of Wound Healing
- ClinicalTrials.gov ID
- NCT02497326
- Acronym / sponsor ID
- 84/RC/KEMU
- Conditions
- Second Degree Burns
- Keywords
- second degree burns, heparin, topical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- 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.
Pain Associated with partial thickness burns (PTB) is very severe and distressing for the patients.Topical conventional treatment of superficial PTB wounds includes application of polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are treated with silvazine cream twice a day and prepared for grafting if not healed within 3 weeks. Existing conventional therapy is un-comfortable and expensive for the patients. Search continues for a reliable, safe, cheap and effective treatment of burn.Topical use of heparin has been found effective in reducing pain associated with burn wounds. More over use of heparin topically in burn patients is easy to perform and cheap but at the moment, evidence of its effectiveness is weak. Current study is being conducted to verify clinical effectiveness of use of heparin in 2nd degree burns by comparing it with topical conventional treatment.
Detailed description
Second degree or partial thickness burn (PTB) is most tricky variety to identify and treat, out of all four categories of burn (based on depth). It is further divided into superficial and deep partial thickness based on the depth of dermal injury. (1) Clinical criteria fulfilling all the points for each category i.e. Superficial PTB (SPTB) being reddish pink, bleed briskly (in <3sec) on pin prick, blanch with brisk return (in <2 sec) on pressure, blister formation and Deep PTB (DPTB) being mottled pink, delayed bleeding (in >3 sec) on pin prick, slow return (in >2 sec) on pressure, no blister, is most commonly used to differentiate both the sub-classes. Pain is hallmark of 2nd degree burns and is treated by topical and IV analgesics. Topical conventional treatment of superficial PTB wounds includes application of polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are treated with silvazine cream twice a day and prepared for grafting by normal saline dressings, if not healed within 3 weeks.
Current treatment for 2nd degree burn is complex, uncomfortable for the patient and expensive for the health systems (2,3) . Search continues for a reliable, safe, cheap and effective treatment of burn. Heparin has been used topically in burn patient and a protocol of topical heparin use has been introduced . It is believed that heparin helps in reducing pain associated with burns and duration of wound healing. (4) It is noted that the mechanism involved in heparin's action on the burn probably derives from its anti-inflammatory and angiogenic properties, stimulating tissue repair and re-epithelializing effects.(2) These actions do not depend on its well-known anticoagulant action. Burn analgesia by heparin is caused by inhibition of pro-inflammatory products which act on free nerve endings and cause pain. In this regard, isolated case reports continue to emerge, suggesting that heparin is able to promote tissue repair and inhibit inflammation in burn patients.(5) It has been shown in a study that out of total 58 patients, those in topical Heparin group demanded less analgesic medications in mg/day (11.83 ± 9.38) than Control group (33.35± 20.63) . It has been reported in another study that heparin applied topically for 5 days in 50 pediatric patients reduced healing time. (6) Indeed there are a number of reports of heparin being used, topically or systemically but there is a lack of effectively controlled studies in this area for clear conclusions to be drawn as to the efficacy of this approach.(7) As it is noted that already existing conventional therapy is un-comfortable and expensive for the patients, use of heparin topically in burn patients is easy to perform and cheap but at the moment, evidence of its effectiveness is weak. So rationale of the study is to verify clinical effectiveness of use of heparin in 2nd degree burns.
Objective:- To compare conventional treatment and topical heparin treatment in 2nd degree burn patients in terms of total consumption of analgesic medication and duration of wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyfax & Lignocain gel or silvazine cream | Active comparator | Drug: Polyfax & Lignocain gel or silvazine cream, Drug: TramadolPolyfax skin ointment plus Lignocain gel will be applied on superficial PTB area and silver sulphadiazine cream on deep PTB in morning and evening after wound wash |
| Topical heparin | Experimental | Drug: Topical Heparin, Drug: TramadolHeparin solution (5000 IU/ml) will be sprinkled aseptically on burn surface twice a day for the first 2 days, by "#27" needle connected via drip set to the drip containing heparin aqueous saline. The dose will be reduced to 75% of day 1 on day 3 and 4 and to 50% on day 5. Administration of heparin saline solution will be in 3 cycles with 5-10 minutes interval. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Either gender with age limits 14-60 years.
- 2nd degree burn with Total burn surface area (TBSA) <20% (assessed by Wallace rule of nine) including front of chest and abdomen, upper limbs excluding hands and lower limbs excluding foot.
- Flame and scald burn (on history).
Key exclusion criteria (4 listed)
- Third degree (painless, lathery eschar with no blanching) and Fourth degree burns (full thickness burn with exposed muscle, tendons or bones) as assessed clinically.
- Chemical or electrical burn (on history).
- Personal or family history of hemorrhagic diathesis, heparin intolerance, any medical illness causing bleeding episodes(e.g, Esophageal varices) or active bleeding from any site.
- History of Liver disease (Total Bilirubin <20umol/L, Alanine amino transferase <36u/L, Aspartate amino transferase <42u/L), or renal disorder (Serum Urea=20-40mg/dl, Serum Creatinine <1.2).
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 |
|---|---|---|
| Polyfax & Lignocain gel or silvazine creamolyfax skin ointment plus Lignocain gel will be applied on superficial PTB area and silver sulphadiazine cream on deep PTB in morning and evening after wound wash. | Drug | Polyfax & Lignocain gel or silvazine cream |
| Topical HeparinHeparin solution (5000 IU/ml) will be sprinkled aseptically on burn surface twice a day for the first 2 days, by "#27" needle connected via drip set to the drip containing heparin aqueous saline. The dose will be reduced to 75% of day 1 on day 3 and 4 and to 50% on day 5. Administration of heparin saline solution will be in 3 cycles with 5-10 minutes interval | Drug | Topical heparin |
| TramadolIV Analgesic ( Inj. Tramadol 10mg/dose) will only be given to the patients (in both groups) having pain score >4, assessed 3 times a day by Numeric Visual Analogue scale (NVAS). | Drug | Polyfax & Lignocain gel or silvazine cream, Topical heparin |
Primary outcome
Total consumption of Analgesic Medication
Time frame: 5 days
Total consumption of Analgesic Medication will be calculated as total of the amount of IV analgesics required (mg/day) by patient, for the first 5 days of treatment, taking day of admission as "day 0". IV Analgesic ( Inj. Tramadol 10mg/dose) will only be given to the patients having pain score >4, assessed 3 times a day by Numeric Visual Analogue scale (NVAS).
Duration of wound healing
Time frame: From date of staring treatment until the date when ≥70% re-epithelialization of SPTB has occured upto 21 days
Duration of Wound Healing in SPTB will be assessed by 1) Noting down the days required for the wound to re-epithelialize ≥70% . The number of day when ≥70% re-epithelialization has occured in SPTB will be noted taking day of starting treatment as 'day zero'
Duration of wound healing
Time frame: Date on Twenty first day after starting treatment untill the date when DPTB ready for skin grafting
Duration of Wound Healing in DPTB will be assessed by noting down days required for the wound to be ready for grafting in taking day 21 after staring treatment as "day 0" Wound will said to be ready for skin grafting if completely (100%) covered by granulation tissue with epithelialized margins.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- BackgroundKlein MB. Thermal,chemical and electrical injuries In:Thorne CH et al.(ed.)Grabb and Smith's plastic surgery.7th ed. Philadelphia,Lippincott Williams & Wilkins;2014. p128 - 129. ISBN 978-1-4511-0955-9.
- Background: PubMed 20339787Barretto MG, Costa Mda G, Serra MC, Afiune JB, Praxedes HE, Pagani E. [Comparative study of conventional and topical heparin treatments for burns analgesia]. Rev Assoc Med Bras (1992). 2010 Jan-Feb;56(1):51-5. doi: 10.1590/s0104-42302010000100016. Portuguese.
- Background: PubMed 18535469Klein MB, Hollingworth W, Rivara FP, Kramer CB, Askay SW, Heimbach DM, Gibran NS. Hospital costs associated with pediatric burn injury. J Burn Care Res. 2008 Jul-Aug;29(4):632-7. doi: 10.1097/BCR.0b013e31817db951.
- BackgroundSaliba MJ Jr. Heparin in the treatment of burns 2011". http://www.salibaburnsinstitute.org/ PROTOCOL.html.
- Background: PubMed 20409713Ferreira Chacon JM, Mello de Andrea ML, Blanes L, Ferreira LM. Effects of topical application of 10,000 IU heparin on patients with perineal dermatitis and second-degree burns treated in a public pediatric hospital. J Tissue Viability. 2010 Nov;19(4):150-8. doi: 10.1016/j.jtv.2010.03.003. Epub 2010 Apr 20.
- Background: PubMed 25278651Venkatachalapathy TS. A comparative study of paediatric thermal burns treated with topical heparin and without heparin. Indian J Surg. 2014 Aug;76(4):282-7. doi: 10.1007/s12262-012-0674-6. Epub 2012 Oct 5.
- Background: PubMed 17925636Oremus M, Hanson MD, Whitlock R, Young E, Archer C, Dal Cin A, Gupta A, Raina P. A systematic review of heparin to treat burn injury. J Burn Care Res. 2007 Nov-Dec;28(6):794-804. doi: 10.1097/BCR.0b013e3181599b9b.
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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.
Muhammad M Bashir principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyfax & Lignocain gel or silvazine cream, Topical Heparin and Tramadol in people with Second Degree Burns, run by King Edward Medical University at 1 site in Pakistan.
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 3 inclusion and 4 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 14 Jul 2015. 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 Pakistan. 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 Muhammad M Bashir, F.C.P.S (923336517745, mmbashir1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total consumption of Analgesic Medication (time frame: 5 days). 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 NCT02497326, which also lists 7 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 14 Jul 2015.