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NCT04030754 Clinical Trial

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

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04030754
Other study ID # 257/RC/KEMU
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 1, 2018
Est. completion date February 14, 2020

Study information
Verified date August 2020
Source King Edward Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 172
Est. completion date February 14, 2020
Est. primary completion date February 14, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• amniotic membrane
amniotic membrane is a biological dressing
• duoderm dressing
duoderm dressing is a synthetic dressing

Locations
Country Name City State
Pakistan King Edward Medical University Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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