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

S

SCARM Institute, Tabriz, Iran

Status and phase

Completed
Phase 2

Conditions

Burn

Treatments

Biological: Autologous epidermal cell suspension
Drug: Silver sulfadiazine ointment

Study type

Interventional

Funder types

Other

Identifiers

NCT03162367
SCARM-Skin-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Autologous epidermal cell suspension group
Experimental group
Treatment:
Biological: Autologous epidermal cell suspension
Silver sulfadiazine ointment group
Active Comparator group
Treatment:
Drug: Silver sulfadiazine ointment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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