- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02497326
Heparin for the Treatment of Burn Wound Pain
Comparative Study of Conventional and Topical Heparin Treatments in Second Degree Burn Patients for Burn Analgesia and Duration of Wound Healing
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad M Bashir, F.C.P.S
- Phone Number: 923336517745
- Email: mmbashir1@gmail.com
Study Contact Backup
- Name: Sobia Manzoor, M.B.B.S
- Phone Number: +923344094072
- Email: drsobiamanzoor@yahoo.com
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Department of Plastic Surgery, Mayo Hospital, King Edward Medical University
-
Contact:
- Muhammad M Bashir, F.C.P.S
- Phone Number: 923336517745
- Email: mmbashir1@gmail.com
-
Contact:
- Sobia Manzoor, M.B.B.S
- Phone Number: +923344094072
- Email: drsobiamanzoor@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Polyfax & Lignocain gel or silvazine cream
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
|
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.
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).
|
Experimental: Topical heparin
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.
|
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).
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
5 days
|
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' |
From date of staring treatment until the date when ≥70% re-epithelialization of SPTB has occured upto 21 days
|
Duration of wound healing
Time Frame: Date on Twenty first day after starting treatment untill the date when DPTB ready for skin grafting
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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.
|
Date on Twenty first day after starting treatment untill the date when DPTB ready for skin grafting
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad M Bashir, King Edward Medical University
Publications and helpful links
General 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.
- Klein 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.
- Saliba 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.
- Venkatachalapathy 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.
- Oremus 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Burns
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Analgesics, Opioid
- Narcotics
- Anticoagulants
- Heparin
- Tramadol
Other Study ID Numbers
- 84/RC/KEMU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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