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NCT Number: NCT03162367

Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn

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.

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sina hospital

Tabriz, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous epidermal cell suspension

Biological

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

Silver sulfadiazine ointment

Drug

the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SCARM Institute, Tabriz, Iran

Other Gov

Registry information

Official study title

Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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