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临床试验/CTRI/2026/01/102139
CTRI/2026/01/102139尚未招募2 期

A Study on the effectiveness and adverse effect profile among patients treated with autoinoculation for multiple viral warts.

Ashwini B1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年2月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
34
试验地点
1

研究概览

简要总结

Warts are papillomatous benign skin outgrowths arising from the epidermis as a result of an infection by human papilloma virus .1 Clinical manifestatations could range from asymptomatic papules, plaques with verrucous surface, pruritis , painful plaques involving any part of skin, mucocutaneous or mucosal tissue leading to cosmetic disfigurement and morbidity with atendency to spread contiguously and distally.2  Depending on the number and site of warts a wide plethora of treatment options are available including topical keratolytics like salicyclic acid, topical podophyllin, imiquimod application, topical sensitizers like dinitrochlorobenzene(DNCB), squaric acid dibutyl ester( SADBE),  radiofrequency monopolar ablation, cryotherapy, ablative CO2 laser, intalesional MMR, intralesional bleomycin. 1 Treatment with the above modalities poses a challenge when warts are multiple in number,

refractory to treatment and recurs following treatment, painful wounds

following electrosurgical or destructive procedures especially when multiple or is located at a site difficult to treat such as over eyelids, peri or subungual area. 1

There is a need for a treatment procedure that involves minimal sittings and is practically simple to perform with minimal wounds, this lead to the development of autoinoculation as a procedure to treat multiple and recurrent warts.

Since the procedure involves a surgical procedure that is being increasingly utilized one is bound to encounter adverse effects both minor and major and a study of the side effects encountered is warranted to examine its potential as an effective treatment modality for viral warts.

•       Patients diagnosed with viral warts between December 2025 to November 2026 attending the Dermatology OPD will be recruited in this study with a minimum sample size of 29 patients.

•Characteristics such as age, sex and duration of warts, any previous administered treatment, history of recurrence is noted, presenting features such as history of itching, pain are noted.

•       Examination findings such as clinical morphology and site of warts is noted. Number of warts and percentage decline is noted at the end of 1st and 3rd month.

•       Autoinoculation procedure is performed as follows:

•       After obtaining informed written consent and obtaining photographs of warts at baseline, routine investigations are done such as complete blood count, random blood sugar, tests for HBsAg, HIV, HCV and other investigations as indicated. Those unvaccinated were administered the tetanus toxoid vaccine prior to procedure. Test dose for 2% lignocaine is administered.

•       The older onset warts are preferred for donor site.

•       Procedure followed is as per description by Lal NR et al3 with minor modifications.

Under sterile aseptic precautions the selected donor wart after administering 2% lignocaine is shave excised using number 15 surgical scalpel blade. The donor site hemostasis is ensured with the coagulation mode of a radiofrequency monopolar

•       probe.

•       The wart tissue excised is cut into small bits using the scalpel blade, the ventral surface is examined for a white surface which is indicative of wart material and placed in a sterile bowl with normal saline.

•       Recipient area is chosen over the ventromedial aspect of the non-dominant arm, palpated to ensure no underlying pulsation and a nick 3 mm long after ensuring asepsis is made using a fresh sterile number 15 surgical blade. Tissue to the medial aspect of this incision is dissected using blunt curved artery forceps to create a subdermal pocket where the wart material obtained is placed and the skin is sutured using 3-0 non absorbable suture material. Hemostasis is ensured and the donor and recipient sites are dressed with topical mupirocin. The patient is given 5 days of oral amoxcillin and clavulanic acid and anti-inflammatory agent in case of pain. Patients were instructed to keep the dressing till 3 days following which it can be changed at a local hospital once in 2 days and to review after 10 days for suture removal.

•       Patients were then asked to follow up after 1 month and 3 months and examined for number of warts and percentage reduction and quantified as <25%, 26-50%, 51 -75% and >75 % improvement if any, worsening or no improvement was also noted. Patients were asked for immediate side effects such as pain, bleeding after 10 days , delayed changes such as secondary infection, contact dermatitis, hyperpigmentation and  new wart at autoinoculation site, side effects at the donor site included hypopigmentation and scarring if any at the end of 1st and 3rd month.

•       probe.

•       The wart tissue excised is cut into small bits using the scalpel blade, the ventral surface is examined for a white surface which is indicative of wart material and placed in a sterile bowl with normal saline.

•       Recipient area is chosen over the ventromedial aspect of the non-dominant arm, palpated to ensure no underlying pulsation and a nick 3 mm long after ensuring asepsis is made using a fresh sterile number 15 surgical blade. Tissue to the medial aspect of this incision is dissected using blunt curved artery forceps to create a subdermal pocket where the wart material obtained is placed and the skin is sutured using 3-0 non absorbable suture material. Hemostasis is ensured and the donor and recipient sites are dressed with topical mupirocin. The patient is given 5 days of oral amoxcillin and clavulanic acid and anti-inflammatory agent in case of pain. Patients were instructed to keep the dressing till 3 days following which it can be changed at a local hospital once in 2 days and to review after 10 days for suture removal.

•       Patients were then asked to follow up after 1 month and 3 months and examined for number of warts and percentage reduction and quantified as <25%, 26-50%, 51 -75% and >75 % improvement if any, worsening or no improvement was also noted. Patients were asked for immediate side effects such as pain, bleeding after 10 days , delayed changes such as secondary infection, contact dermatitis, hyperpigmentation and  new wart at autoinoculation site, side effects at the donor site included hypopigmentation and scarring if any at the end of 1st and 3rd month.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All diagnosed cases of warts more than five in number Patients with naive or recurrent or treatment unresponsive warts Patients willing to undergo the procedure of autoinoculation.

排除标准

  • Pregnancy and lactating mothers Patients with bleeding diathesis Patients with serious systemic illness Immunocompromised patients due to disease or drugs Patients who are not mentally fit so as to understand the nature of procedure and possible adverse effects.

研究者

发起方
Ashwini B
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ashwini B

Associate Professor

研究点 (1)

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