Four chamber method in vitiligo surgery, a ray of hope in small setups

Completed

• Conditions: Vitiligo

• Registration Number: CTRI/2017/12/010980
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary

Non cultured epidermal cell suspension (NCES) is a well established cellular grafting technique in stable vitiligo. However, NCES preparation by Lab conventionally involves creation of laboratory facilities and need for special equipments. There is no need for trypsin inhibitors, pipettes, autoclaved tips, centrifuge tube and centrifuge machine in Four chamber (FC) method. With the introduction of  FC method the clinician’s in a small set up who do not have access to laboratory facilities will be able to perform vitiligo surgeries at peripheral level at a minimal cost. A total of 30 stable vitiligo patients with bilaterally symmetrical patches or multiple patches in same anatomical area were recruited for the study. Using random number tables the matched patches were treated with either conventional NCES or NCES prepared by FC method in same patient. Each patient was evaluated at 4, 8, 16 weeks post surgery by a blinded observer in regard to extent of repigmentation, colour match, change in patient satisfaction with patient global assessment (PGA) questionnaire. In the study at the follow up period of 16 weeks, the extent of repigmentation was excellent 36.6% in group A compared to 34.1%in group B which showed no statistical significance (p=1.00).  Marked repigmentation was also seen in in 34.1% of patches in each group. Diffuse repigmentation was seen in 29 (70.7%) out of 41 lesions in group A and 31 (75.6%) out of 41 lesions in group B (p=0.62). On resistant sites repigmentation was good, 33.3% in group A and 27.8% in group B (p=0.72); while it was excellent, 22.2% each in group A and B. Thirty four paired patches were of  either vitiligo vulgaris and acrofacialvitiligo) in which repigmentation was good, 38.2 % in group A and 35.3 % in group B (p=0.80); while it was excellent in 32.4 % in group A and 29.4 % in group B (p=0.79). There was also no statistical difference in the pattern of repigmentation, colour match and PGA. It can be concluded that preparation of NCES by FC method is efficacious and a cost effective cellular transplantation technique in stable vitiligo with results comparable to conventional NCES.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-30
• Study Completion: 2015-10-30
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Subjects with clinical diagnosis of focal, segmental or generalized vitiligo which has been stable for more than 1year.
• Vitiligo patches should be in same anatomical region bilaterally or two or more patches in the same anatomical region separated by a stretch of normal skin (at least 1cm).

Exclusion Criteria

1)Age less than 10 years 2)Pregnancy 3)Patient with actively spreading vitiligo 4)Appearance of new lesions 5)History of Koebnerization 6)History of hypertrophic scars or keloidal tendency 7)Bleeding disorders 8)Patients with unrealistic expectation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of repigmentation	16 weeks

Secondary Outcome Measures

Name	Time	Method
Pattern of repigmentation.	Correlation extent of repigmentation with type of vitiligo and site of surgery

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sahil Mrigpuri

Principal investigator

8872551999

sahil57mrigpuri@gmail.com