Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Novel Surgical Method in the Treatment of Unstable Vitiligo

NCT03013049

Vitiligo

UNKNOWN NA

A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites

NCT01722994

Wound Closure Technique

COMPLETED PHASE4

Minimally Invasive Treatment Methods for Pilonidal Disease

NCT03070028

Pilonidal Sinus

COMPLETED NA

A Trial Comparing Stapled Versus Monocryl Sutured Skin Closure for Elective Open Colectomy

NCT01907542

Wound Infection

UNKNOWN NA

Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

NCT07078669

Wound Closure Suture Materials

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitiligo

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mini Punch Grafting

Group Type ACTIVE_COMPARATOR

MINI PUNCH GRAFTING

Intervention Type 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).

Suction Blister Epidermal Grafting

Group Type ACTIVE_COMPARATOR

SUCTION BLISTER EPIDERMAL GRAFTING

Intervention Type 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).

Non Cultured Epidermal Cell Suspension

Group Type ACTIVE_COMPARATOR

NON CULTURED EPIDERMAL CELL SUSPENSION

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SUCTION BLISTER EPIDERMAL GRAFTING

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).

Intervention Type PROCEDURE

MINI PUNCH GRAFTING

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).

Intervention Type PROCEDURE

NON CULTURED EPIDERMAL CELL SUSPENSION

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No