Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients

NCT03717025 | Unknown

• 1 other identifier: INT/IEC/2017/1251
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitiligo

Keywords

ACRAL

Outcome Measures

Primary Outcomes (1)

• 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

  Repigmentation will be assessed at 12 weeks.

Secondary Outcomes (5)

• Color Matching of Repigmented Area

  Assessment at 12 weeks.

• Patient's Quality of Life Post Surgery

  Assessment at 12 weeks.

• Patient's Quality of Life Post Surgery

  Assessment at 12 weeks.

• PATTERN OF REPIGMENTATION

  Assessment at 12 weeks.

• ADVERSE EVENTS

  Assessment at 4, 8 and 12 weeks.

Study Arms (3)

Mini Punch Grafting

ACTIVE COMPARATOR

Procedure: MINI PUNCH GRAFTING

Suction Blister Epidermal Grafting

ACTIVE COMPARATOR

Procedure: SUCTION BLISTER EPIDERMAL GRAFTING

Non Cultured Epidermal Cell Suspension

ACTIVE COMPARATOR

Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION

Interventions

SUCTION BLISTER EPIDERMAL GRAFTING PROCEDURE

1. Preferred donor sites for making blister is lateral aspect of upper thigh. The area is shaved and cleansed with surgical spirit. 2. Blister formation is induced by using suction apparatus. 3. Recipient site is surgically prepared by doing dermabrasion. 4. 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. 5. The graft is firmly pressed with sterile moist gauze to remove any underneath serous collection. 6. The pressure dressing is done with double layer framycetin tulle, moist gauze and bandage. 7. Donor area is dressed with dry sterile pads. 8. The part is immobilized and Antibiotics and Analgesic are given till dressing are removed (after 5-7 days).

Suction Blister Epidermal Grafting

MINI PUNCH GRAFTING PROCEDURE

1. Recipient area is prepared first after shaving and cleaning with surgical spirit. 2 % lignocaine with or without adrenalin will be infiltrated as local aneasthetic. 2. The punched out chambers are spaced at a gap of less than 5 mm (preferably 2 - 2.5 mm) from each other. 3. The donor area is either upper lateral portion of thigh or gluteal region. 4. 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. 5. Hemostasis is achieved by pressing a saline soaked gauze piece over the area. 6. For the recipient area 3 layers of dressing from inside out are : paraffin embedded non adherent sterile gauze, sterile surgipad, and micropore. 7. For the donor area only surgipad and micropore are used. 8. Immobilisation of recipient area is advised along with antibiotics and analgesics till removal of dressing (after 4-7 days).

Mini Punch Grafting

NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE

1. About one-tenth the size of recipient area is selected as the donor site. 2. Split thickness skin graft is taken under aseptic precautions with the help of a shaving blade held firmly by a straight artery forceps. 3. The area is dressed with Bactigras gauze. 4. Split thickness skin specimen is transferred under aseptic conditions to a container with Normal Saline and transferred to laboratory for preparing suspension. 5. Recipient site is dermabraded under aseptic precautions until tiny pinpoint bleeding spots are seen. 6. Epidermal cell suspension is carefully transferred to a tuberculin syringe. 7. With 18 gauge needle attached to this syringe, suspension is spread evenly on dermabraded recipient site. 8. This is then covered with Collagen dressing, followed by bactigras, guaze and tegaderm dressings from inside to outside. 9. The patient is observed for 2 hours after performing the procedure and given antibiotics and analgesics for 5-7 days till dressing removal.

Non Cultured Epidermal Cell Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR, DEPARTMENT OF DERMATOLOGY

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 23, 2018
• Study Start: July 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

IN (1)