Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients

• ClinicalTrials.gov Identifier: NCT03717025
• Recruitment Status: Unknown
• First Posted: October 23, 2018
• Last Update Posted: October 23, 2018
• Sponsor: Postgraduate Institute of Medical Education and Research
• Information provided by (Responsible Party): Davinder Parsad, Postgraduate Institute of Medical Education and Research

Study Description

Brief Summary:

Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.

Condition or disease	Intervention/treatment	Phase
Vitiligo	Procedure: SUCTION BLISTER EPIDERMAL GRAFTING; Procedure: MINI PUNCH GRAFTING; Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 1, 2017
• Estimated Primary Completion Date: October 2018
• Estimated Study Completion Date: November 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Mini Punch Grafting	Procedure: MINI PUNCH GRAFTING; 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).
Active Comparator: Suction Blister Epidermal Grafting	Procedure: SUCTION BLISTER EPIDERMAL GRAFTING; 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).
Active Comparator: Non Cultured Epidermal Cell Suspension	Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION; 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.

Outcome Measures

Primary Outcome Measures :

1. Repigmentation At Surgery Site [ Time Frame: Repigmentation will be assessed at 12 weeks. ]

   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 :

1. Color Matching of Repigmented Area [ Time Frame: Assessment at 12 weeks. ]
   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.
2. Patient's Quality of Life Post Surgery [ Time Frame: Assessment at 12 weeks. ]
   Patient satisfaction will be assessed using Patient Global Assessment score.
3. Patient's Quality of Life Post Surgery [ Time Frame: Assessment at 12 weeks. ]
   Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
4. PATTERN OF REPIGMENTATION [ Time Frame: Assessment at 12 weeks. ]
   Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'.
5. ADVERSE EVENTS [ Time Frame: Assessment at 4, 8 and 12 weeks. ]
   Adverse events both at recipient and donor sites.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
2. Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
3. Vitiligo lesions has been stable for 1 year.
4. 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.
5. Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.

Exclusion Criteria:

1. Age less than 18 years
2. Pregnancy and lactation
3. Patient with actively spreading vitiligo
4. History of Koebnerisation
5. History of hypertrophic scars or keloidal tendency
6. Bleeding disorders
7. Patients with unrealistic expectation

Contacts and Locations

Locations

India

Post Graduate Institute of Medical Education and Research; Recruiting

Chandigarh, India, 160012

Contact: MUTHU SENDHIL KUMARAN, ASSOCIATE PROFESSOR 9876930521 ext 91 drsen_2000@yahoo.com

Contact: AMIT KUMAR, JUNIOR RESIDENT 7347638076 ext 91 amitdalla615@gmaiil.com

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

More Information

• Responsible Party: Davinder Parsad, PROFESSOR, DEPARTMENT OF DERMATOLOGY, Postgraduate Institute of Medical Education and Research
• ClinicalTrials.gov Identifier: NCT03717025
• Other Study ID Numbers: INT/IEC/2017/1251
• First Posted: October 23, 2018
• Last Update Posted: October 23, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Overall results of the study will be available to other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Davinder Parsad, Postgraduate Institute of Medical Education and Research:

ACRAL

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases