The Effect of Autologous Non-cultured Melanocyte-Keratinocyte Cell Suspension in Comparison with Split Skin Grafting on Re-pigmentation of Post-burn Leukoderma: A Randomized Control Trial
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Abstract
Objectives:
Primary objective: To compare the efficacy of Autologous Non- Cultured Melanocyte-Keratinocyte Cell Suspension (MKS) with Split Skin Grafting (SSG) on producing adequate pigmentation among patients with post-burn leukoderma
Secondary objective(s):
i. To compare time to full healing of donor site between the patients treated with noncultured autologous MKS and SSG
ii. To compare satisfaction scores between patients treated with MKS and SSG
Design: Open-label, non-blinded, single-center, closed sealed envelope, randomized controlled trial.
Setting: Department of Plastic Surgery and Tertiary Burn Care Centre, in South India
Participants: Patients above 12 years of age with previously untreated post-burn leukoderma attending the out-patient department.
Intervention: Participants were randomized by block randomization using a closed-sealed envelope method to receive treatment for post-burn leukoderma (PBL) into two groups. Intervention arm patients were treated with MKS and control arm patients were treated with SSG group.
Main Outcome Measures: Percentage of re-pigmentation after 3 months of intervention, time to donor site healing and patient satisfaction score
Result: Forty-eight patients with post-burn leukoderma were randomly allocated to receive either split-skin graft (Group 1) or autologous non-cultured melanocyte-keratinocyte cell suspension (Group 2). Re-pigmentation was significantly better in a split skin graft group (Group 1) at 12 weeks. Patient satisfaction scores were better in Group 1, and there were no significant differences in the donor site healing time in both groups.
Interpretation: Early (12 weeks) pigmentation is better achieved in post-burn leukoderma patches treated with SSG, while reduced donor skin requirement and reduced donor complications are noted in patients treated with non-cultured MKS Trial registration: The trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2019/04/018804
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