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Trial record 1 of 1 for:    Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn
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Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03162367
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
SCARM Institute, Tabriz, Iran

Brief Summary:
Different medical treatments are available for treatment of skin burns such as skin grafts and silver sulfadiazine ointment. These treatments are used for second degree burn as routine technique in burns units. Cell therapy is a new approach for treatment of skin disease.In this study we use autologous epidermal cell suspension to achieve better cosmetic and functional results in treatment of second degree burn.

Condition or disease Intervention/treatment Phase
Burn Biological: Autologous epidermal cell suspension Drug: Silver sulfadiazine ointment Phase 2

Detailed Description:
In this study 20 patients in Burn Department of Sina Hospital Tabriz, with at least 2 areas of second degree burn randomly choose. First skin samples are taken from normal skin by 4mm punch and send to the laboratory for preparation of epidermal cell suspension and this suspension is transferred to the one area of second degree burn in each patient and the other area in the same patient dresses by silver sulfadiazine ointment. The dressing changes are followed up for 12h for first assessment of therapy until 10th day after intervention. In the days of 5, 10, 15 and 20 the percentage of re-epithelization for each treatment will be measured. After 2 months, patients are visited and any complications check for scar formation, pain, post inflammatory hyper-pigmentation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Autologous epidermal cell suspension group Biological: Autologous epidermal cell suspension
First skin samples taken from normal skin by 4mm punch will be send to laboratory for preparation of epidermal cell suspension and this suspension transfer to one area of second degree burn

Active Comparator: Silver sulfadiazine ointment group Drug: Silver sulfadiazine ointment
the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day




Primary Outcome Measures :
  1. Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline [ Time Frame: up to 20 days ]
    Measurement the percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; >90%=complete)

  2. Change in re-epithelization rate with silver sulfadiazine ointment from Baseline [ Time Frame: up to 20 days ]
    Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; >90%=complete)


Secondary Outcome Measures :
  1. Scar formation [ Time Frame: After 2 month ]
    Observe patient and take photo

  2. Post inflammatory hyperpigmentation [ Time Frame: After 2 month ]
    Observe patient and take photo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy patient with second degree burn admitted in burn unit

Exclusion Criteria:

  • Pregnancy-lactation
  • Immunosuppression like receiving chemotherapy or radiotherapy
  • Patient unsatisfied to going on study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162367


Locations
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Iran, Islamic Republic of
Sina hospital
Tabriz, Iran, Islamic Republic of
Sponsors and Collaborators
SCARM Institute, Tabriz, Iran
Investigators
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Study Director: Mohamad Reza Ranjkesh, MD, Dermatologist SCARM institute
Publications of Results:
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Responsible Party: SCARM Institute, Tabriz, Iran
ClinicalTrials.gov Identifier: NCT03162367    
Other Study ID Numbers: SCARM-Skin-002
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SCARM Institute, Tabriz, Iran:
Burn
Epidermal cell suspension
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Sulfadiazine
Silver Sulfadiazine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local