Clinical trial NCT03162367: Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn
Official title: Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burn
Keywords: Burn
Epidermal cell suspension
Lead sponsor: SCARM Institute, Tabriz, Iran
Sponsor class: OTHER_GOV
First posted: 2017-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline
timeFrame: up to 20 days
measure: Change in re-epithelization rate with silver sulfadiazine ointment from Baseline
timeFrame: up to 20 days
Secondary outcomes:
measure: Scar formation
timeFrame: After 2 month
measure: Post inflammatory hyperpigmentation
timeFrame: After 2 month
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Sina hospital
Study officials:
affiliation: SCARM institute
name: Mohamad Reza Ranjkesh, MD, Dermatologist
role: STUDY_DIRECTOR
References:
citation: You HJ, Han SK. Cell therapy for wound healing. J Korean Med Sci. 2014 Mar;29(3):311-9. doi: 10.3346/jkms.2014.29.3.311. Epub 2014 Feb 27.
citation: Zhao H, Chen Y, Zhang C, Fu X. Autologous epidermal cell suspension: A promising treatment for chronic wounds. J Tissue Viability. 2016 Feb;25(1):50-6. doi: 10.1016/j.jtv.2015.11.003. Epub 2015 Dec 8.
citation: Mcheik JN, Barrault C, Levard G, Morel F, Bernard FX, Lecron JC. Epidermal healing in burns: autologous keratinocyte transplantation as a standard procedure: update and perspective. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e218. doi: 10.1097/GOX.0000000000000176. eCollection 2014 Sep.
citation: Gardien KL, Marck RE, Bloemen MC, Waaijman T, Gibbs S, Ulrich MM, Middelkoop E; Dutch Outback Study Group1. Outcome of Burns Treated With Autologous Cultured Proliferating Epidermal Cells: A Prospective Randomized Multicenter Intrapatient Comparative Trial. Cell Transplant. 2016;25(3):437-48. doi: 10.3727/096368915X689569. Epub 2015 Sep 28.