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Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burns

NCT04030754 — Phase 2 / Phase 3, Completed, 172 participants, King Edward Medical University

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Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burn Patients: a Randomized Controlled Trial

RegistryNCT04030754
StatusCompleted
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment172 (Actual)
SponsorKing Edward Medical University (Other)
ConditionsBurns
Interventionsamniotic membrane, duoderm dressing (Combination product)
Datesstart 2018-11-01, primary completion 2020-02-14, completion 2020-02-14, first posted 2019-07-24, last updated 2020-09-01
Locations1 site in Pakistan

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-Summary

There is a difference in frequency of wound infection, mean pain score, mean of time for skin grafting and hospital stay in pediatric 2nd and 3rd degree burns, between amniotic membrane and duoderm dressings

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+Detailed description

After informed consent of the patients, patients who will fulfill the inclusion and exclusion criteria will be enrolled in the study from Department of Pediatric Surgery, Mayo Hospital Lahore and will be randomly allocated by lottery method into 2 groups by the doctor. Group A and B with 86 patients in each group. Group A patients will be undergoing amniotic membrane dressing, while group B patients will undergo colloid gel foam dressing. Basic demographic information will be noted. Effect modifiers (hemoglobin level, weight and height) will be noted.

In group A, the wounds will be washed with normal saline and then covered with amniotic membrane over which a layer of Vaseline gauze will be applied and dressing with gauze and the crape bandage will be applied. Every 3-4 days these dressings will be changed and assessed for pain, wound infection and wound c/s will be sent. Placentas from clean vaginal deliveries and elective C-sections will be taken. Blood of mother will be screened. Amniotic membrane will be separated from placenta in a clean sterile bowl. Bowl will be put in refrigerator at 4 degrees.

In group B, wound will be washed with normal saline . The wound site will be covered with Colloid Gel Foam and gauze, and crape bandage will be applied. Dressing will be changed after 3-4 days. The outcome (pain score, wound infection,time for skin grafting and hospital stay) will be compared in both groups.

+Arms and interventions

ArmTypeInterventionsDescription
amniotic membrane groupExperimentalCombination Product: amniotic membraneamniotic dressing will be applied to these patients
duoderm groupExperimentalCombination Product: duoderm dressingduoderm dressing will be applied to these patients as intervention
  • amniotic membrane (Combination product): amniotic membrane is a biological dressing
  • duoderm dressing (Combination product): duoderm dressing is a synthetic dressing

+Outcome measures

Primary outcomes

  • mean time for skin grafting [average time will be 21 days]: time for grafting when wound has healthy granulation tissue
  • frequency of wound infection [at 5th day of dressing]: redness around burnt wound, tenderness, swelling, increased temperature (>4 degrees), exudation and growth on wound cultures
  • mean of hospital stay [at the time of discharge, that can be from 7th day to 30th day]: time at which patient wound is completely healed and no wound infection present, average time will be up to 30 days
  • mean of pain for patients of age <8 years assessed by Visual Analogue Score [at 5th day of dressing change]: pain will be assessed at the time of dressing change. for patients<8 years of age visual analogue score will be used.
  • mean of pain for patients of age >8 years assessed by Face, Leg, Activity, Cry, Consolabilty Pain Scale. [at 5th day of dressing change]: FLACC (face,leg, activity, cry, consolability) pain scale will be used

+Eligibility

Sex: All, ages: 1 Year to 12 Years

Inclusion Criteria:

* 10-45 % percent 2nd and 3rd degree fresh burns age less than 12 years patients of both gender

Exclusion Criteria:

* patients whose parents are not willing patients whose wound c/s comes positive at the time of admission patients who have associated medical disorder and trauma.

+Locations (1)

FacilityCityCountryStatus
King Edward Medical UniversityLahore, Punjab ProvincePakistan

+Publications

  • Al Ibran E, Mirza FH, Memon AA, Farooq MZ, Hassan M. Mortality associated with burn injury - a cross sectional study from Karachi, Pakistan. BMC Res Notes. 2013 Dec 19;6:545. doi: 10.1186/1756-0500-6-545. PMID 24354896
  • Mohammadi AA, Johari HG, Eskandari S. Effect of amniotic membrane on graft take in extremity burns. Burns. 2013 Sep;39(6):1137-41. doi: 10.1016/j.burns.2013.01.017. Epub 2013 Mar 21. PMID 23523222
  • Martin FT, O'Sullivan JB, Regan PJ, McCann J, Kelly JL. Hydrocolloid dressing in pediatric burns may decrease operative intervention rates. J Pediatr Surg. 2010 Mar;45(3):600-5. doi: 10.1016/j.jpedsurg.2009.09.037. PMID 20223327
  • Eskandarlou M, Azimi M, Rabiee S, Seif Rabiee MA. The Healing Effect of Amniotic Membrane in Burn Patients. World J Plast Surg. 2016 Jan;5(1):39-44. PMID 27308239

+Investigators

  • fatima naumeri, mbbs, fcps, Principal investigator, King Edward Medical University

My Notes