Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
Primary Purpose
Vitiligo
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SUCTION BLISTER EPIDERMAL GRAFTING
MINI PUNCH GRAFTING
NON CULTURED EPIDERMAL CELL SUSPENSION
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring ACRAL
Eligibility Criteria
Inclusion Criteria:
- Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
- Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
- Vitiligo lesions has been stable for 1 year.
- Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo which inturn are located on acral areas and bony prominences.
- Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
Exclusion Criteria:
- Age less than 18 years
- Pregnancy and lactation
- Patient with actively spreading vitiligo
- History of Koebnerisation
- History of hypertrophic scars or keloidal tendency
- Bleeding disorders
- Patients with unrealistic expectation
Sites / Locations
- Post Graduate Institute of Medical Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Mini Punch Grafting
Suction Blister Epidermal Grafting
Non Cultured Epidermal Cell Suspension
Arm Description
Outcomes
Primary Outcome Measures
Repigmentation At Surgery Site
To assess the difference in extent of repigmentation of the surgery site by three different methods at 12 weeks of post treatment follow up in a given patient.
Repigmentation will be assessed as follows:
≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation
Secondary Outcome Measures
Color Matching of Repigmented Area
Color matching of the repigmented area with the surrounding normal skin will be done in each case as 'somewhat lighter than', 'same as' or 'somewhat darker than' normal skin.
Patient's Quality of Life Post Surgery
Patient satisfaction will be assessed using Patient Global Assessment score.
Patient's Quality of Life Post Surgery
Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
PATTERN OF REPIGMENTATION
Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'.
ADVERSE EVENTS
Adverse events both at recipient and donor sites.
Full Information
NCT ID
NCT03717025
First Posted
October 16, 2018
Last Updated
October 22, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT03717025
Brief Title
Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
Official Title
A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.
Detailed Description
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the main stay of treatment, it is not effective in all and residual lesions need augmented surgical treatment later for further completion of repigmentation.
Now a day surgical modalities have become treatment of choice for stable vitiligo not responding to medical treatment although there are numerous sites which do not respond that well to surgical procedure as well. The investigators ought to compare the efficacy of 3 well established surgical methods i.e. Mini Punch Grafting vs Suction Blister Epidermal Grafting vs Non Cultured Epidermal cell Suspension on stable vitiligo patches localized to acral areas and bony prominences like elbows, knees and ankles. Out of all the vitiligo patches in a given participant, 3 different patches on acral and bony areas will be chosen and participants will be treated with 3 different methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
ACRAL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mini Punch Grafting
Arm Type
Active Comparator
Arm Title
Suction Blister Epidermal Grafting
Arm Type
Active Comparator
Arm Title
Non Cultured Epidermal Cell Suspension
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
SUCTION BLISTER EPIDERMAL GRAFTING
Intervention Description
Preferred donor sites for making blister is lateral aspect of upper thigh. The area is shaved and cleansed with surgical spirit.
Blister formation is induced by using suction apparatus.
Recipient site is surgically prepared by doing dermabrasion.
After formation of blisters, each blister is gently cleansed with normal saline and cut all along its border with curved iris scissors parallel to the skin surface. The roof is everted over the thumb with dermal surface facing upwards and then with the help of blunt end of forceps it is placed on the recipient area.
The graft is firmly pressed with sterile moist gauze to remove any underneath serous collection.
The pressure dressing is done with double layer framycetin tulle, moist gauze and bandage.
Donor area is dressed with dry sterile pads.
The part is immobilized and Antibiotics and Analgesic are given till dressing are removed (after 5-7 days).
Intervention Type
Procedure
Intervention Name(s)
MINI PUNCH GRAFTING
Intervention Description
Recipient area is prepared first after shaving and cleaning with surgical spirit. 2 % lignocaine with or without adrenalin will be infiltrated as local aneasthetic.
The punched out chambers are spaced at a gap of less than 5 mm (preferably 2 - 2.5 mm) from each other.
The donor area is either upper lateral portion of thigh or gluteal region.
Grafts are placed directly from donor to the recipient area. Care is taken, so that graft edges are not folded, the tissue is not crushed or placed upside down.
Hemostasis is achieved by pressing a saline soaked gauze piece over the area.
For the recipient area 3 layers of dressing from inside out are : paraffin embedded non adherent sterile gauze, sterile surgipad, and micropore.
For the donor area only surgipad and micropore are used.
Immobilisation of recipient area is advised along with antibiotics and analgesics till removal of dressing (after 4-7 days).
Intervention Type
Procedure
Intervention Name(s)
NON CULTURED EPIDERMAL CELL SUSPENSION
Intervention Description
About one-tenth the size of recipient area is selected as the donor site.
Split thickness skin graft is taken under aseptic precautions with the help of a shaving blade held firmly by a straight artery forceps.
The area is dressed with Bactigras gauze.
Split thickness skin specimen is transferred under aseptic conditions to a container with Normal Saline and transferred to laboratory for preparing suspension.
Recipient site is dermabraded under aseptic precautions until tiny pinpoint bleeding spots are seen.
Epidermal cell suspension is carefully transferred to a tuberculin syringe.
With 18 gauge needle attached to this syringe, suspension is spread evenly on dermabraded recipient site.
This is then covered with Collagen dressing, followed by bactigras, guaze and tegaderm dressings from inside to outside.
The patient is observed for 2 hours after performing the procedure and given antibiotics and analgesics for 5-7 days till dressing removal.
Primary Outcome Measure Information:
Title
Repigmentation At Surgery Site
Description
To assess the difference in extent of repigmentation of the surgery site by three different methods at 12 weeks of post treatment follow up in a given patient.
Repigmentation will be assessed as follows:
≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation
Time Frame
Repigmentation will be assessed at 12 weeks.
Secondary Outcome Measure Information:
Title
Color Matching of Repigmented Area
Description
Color matching of the repigmented area with the surrounding normal skin will be done in each case as 'somewhat lighter than', 'same as' or 'somewhat darker than' normal skin.
Time Frame
Assessment at 12 weeks.
Title
Patient's Quality of Life Post Surgery
Description
Patient satisfaction will be assessed using Patient Global Assessment score.
Time Frame
Assessment at 12 weeks.
Title
Patient's Quality of Life Post Surgery
Description
Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
Time Frame
Assessment at 12 weeks.
Title
PATTERN OF REPIGMENTATION
Description
Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'.
Time Frame
Assessment at 12 weeks.
Title
ADVERSE EVENTS
Description
Adverse events both at recipient and donor sites.
Time Frame
Assessment at 4, 8 and 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
Vitiligo lesions has been stable for 1 year.
Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo which inturn are located on acral areas and bony prominences.
Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
Exclusion Criteria:
Age less than 18 years
Pregnancy and lactation
Patient with actively spreading vitiligo
History of Koebnerisation
History of hypertrophic scars or keloidal tendency
Bleeding disorders
Patients with unrealistic expectation
Facility Information:
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MUTHU SENDHIL KUMARAN, ASSOCIATE PROFESSOR
Phone
9876930521
Ext
91
Email
drsen_2000@yahoo.com
First Name & Middle Initial & Last Name & Degree
AMIT KUMAR, JUNIOR RESIDENT
Phone
7347638076
Ext
91
Email
amitdalla615@gmaiil.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Overall results of the study will be available to other researchers.
Learn more about this trial
Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
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