Study On Skin Graft With And Without Jalaukavacharn And Yashtimadhu Kwatha Prakshalana As Pretreatment In Management Of Ulcer Which Not Healed Since Long Term

Phase 3

Not yet recruiting

Conditions: Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH,

Registration Number: CTRI/2025/04/085653

Lead Sponsor: Government Akhandanand Ayurved College and Hospital

Brief Summary: Every year chronic wounds affect a large number of population and severely reduce their quality of life. Current statistic indicate that nearly 6 million people suffer due to chronic wounds worldwide. There are very small number of Indian studies available on the epidemiology of chronic wounds. According to journal of wound care, the prevalence rate of chronic wounds in the community was reported as 4.5 per 1000 population whereas that of acute wound was nearly doubled at 10.5 per 1000 population. "The causes for chronic wounds are many, including such systemic conditions atherosclerosis, diabetes mellitus, leprosy and tuberculosis. Other major causes include venous ulcers, pressure sores, trauma, and vasculitis.

As described by Acharya Sushruta, Skin grafting is most useful surgical procedure in present era. Splits thickness skin grafting or STSG is one of the types of skin grafting. But skin grafting may be unsuccessful for numerous reasons. The most common cause for skin graft rejection is hematoma beneath the graft. Similarly, seroma formation may prevent graft adherence to the underlying wound bed, preventing the graft from receiving the necessary nourishment, as detailed above. Movement of the graft or shear forces may also lead to graft failure through disruption of the fragile attachment of the graft to the wound bed. Another common source of failure is a poor recipient site. The wound may have poor vascularity, or the surface contamination may have been too great to allow graft rejection. Infection is also most common cause of graft rejection. According to one study, graft loss secondary to infection was recorded in 31 patients . The microbiological cultures revealed Pseudomonas aeruginosa in 58.1 percentage of the cases, followed by Enterobacter, Staphylococcus aurus, Acinetobacter enterococci.\*

The leech produces a number of important substances which contribute to the special property of the bite, including an anticoagulant, a local vasodilator and local anesthetic. Like Hirudin, Hyaluronidase, Hementin etc. They secrete anticoagulants to prevent blood clots and relieve pressure due to pooling blood Leech saliva helps to re-establish bloodflow means of a vasodilator. Deprive blood clots and decreased chances of venous the graft in recipient area, it established the connection with recipient bed by 3 stages: Plasmic Imbibition, Inosculation and Neovascularization. After the combined effect of leech saliva, it stasis. Increased fresh and oxygenated blood to the ulcer area increase viable tissue to the ulcer. Decrease infection and dead tissue. After placing facilitates the acceptance of graft. Thus this novel study will beneficial for future plastic and reconstructive surgery.

In the treatment of all types of wounds and inflammations Yashtimadhu is considered as the drug of choice.

In inflammatory conditions of the eye and various types of Vrana, Chakradutta has advocated the use of this drug. Acharya Charaka has advocated the use of this drug in Vataja and Raktaja diseases at various places. In Sushruta Samhita also described its use in pain in various surgical and medical diseases. Yashtimadhu has Madhura Rasa, Sheeta Virya, Madhura Vipaka and is Vata-Pitta Shamaka. Moreover, studies conducted on modern scientific parameters have proved the healing, anti- ulcer, anti-inflammatory and skin regeneration activity of Yashtimadhu. Sodium glycyrrhizate possessed anti ulcer activity and stimulation of regeneration of skin.

Pre treatment of Jalaukavacharanaa shows significant results in STSG in the the management of dushta varna(Chronic non healing ulcer). Salivary secretion of jalauka deprived blood clots and decreased chances of venous stasis. Increased fresh and oxygenated blood to the ulcer area increase viable tissue to the ulcer, decrease infection and dead tissue, due to proper venous drainage established by jalaukavacharana neovascularisation easily established. Due to proper nutrition supply plasmtic imbibition also take place.

So acceptance of the graft will increase after jalaukavacharan and yastimadhu kwatha prakshalan.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients with Sign and symptoms of Dushta vranaxix Chronic Non healing Ulcer Patients with previously rejected skin grafts Age greater than is equal to 18 and less than is equal to 60 years Patients are selected irrespective of caste gender and religion Patient with single ulcer with size less than 7cm lenth 7cm wide will be include in study HbA1c level is less than is equal to 7 Patient with blood pressure is less then is equal to 150 systolic 90 diastolic mmHg Venous ulcer Diabetic ulcer Traumatic wound which fail to heal Infectious ulcer Pressure sore.

Exclusion Criteria

Patients with infectious diseases like HBsAg AIDS Patients with any coagulopathy like Haemophilia Vulnerable group of people like mentally ill Immunocompromised patients Pressure sore on sole.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Effect Of Two Therapies on acceptance and Rejection Of Graft	60 days

Secondary Outcome Measures

Name	Time	Method
Improve Quality Of Life Of Patient	60 days

Trial Locations

Locations (1): Government Akhandanand Ayurved College and Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Government Akhandanand Ayurved College and Hospital
🇮🇳Ahmadabad, GUJARAT, India
Mayuriben Kamleshgiri Goswami
Principal investigator
7567474801
goswamimayuri99@gmail.com