Clinical Trials Logo
  1. Home
  2. Burns
  3. NCT04030754
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A

External Links