NCT02497326

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

July 7, 2015

Last Update Submit

July 10, 2015

Conditions

Second Degree Burns

Keywords

second degree burnsheparintopical

Outcome Measures

Primary Outcomes (3)

  • 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).

    5 days

  • Duration of wound healing

    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

    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

Study Arms (2)

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

Drug: Polyfax & Lignocain gel or silvazine creamDrug: 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.

Drug: Topical HeparinDrug: Tramadol

Interventions

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.

Polyfax & Lignocain gel or silvazine cream
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

Topical heparin
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).

Polyfax & Lignocain gel or silvazine creamTopical heparin

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Either gender with age limits 14-60 years.
  • nd 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic Surgery, Mayo Hospital, King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (7)

  • 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.

    BACKGROUND

  • 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.

    PMID: 20339787BACKGROUND

  • 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.

    PMID: 18535469BACKGROUND

  • Saliba MJ Jr. Heparin in the treatment of burns 2011". http://www.salibaburnsinstitute.org/ PROTOCOL.html.

    BACKGROUND

  • 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.

    PMID: 20409713BACKGROUND

  • 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.

    PMID: 25278651BACKGROUND

  • 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.

    PMID: 17925636BACKGROUND

MeSH Terms

Interventions

bacitracin, polymyxin B drug combinationHeparinTramadol

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Muhammad M Bashir

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad M Bashir, F.C.P.S

CONTACT

923336517745mmbashir1@gmail.com

Sobia Manzoor, M.B.B.S

CONTACT

+923344094072drsobiamanzoor@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Plastic Surgery

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 14, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

PA(1)