Biocompatible & Biodegradable Polymeric Skin Grafts for Wounds

Phase 1

• Conditions: Health Condition 1: T758- Other specified effects of external causes

• Registration Number: CTRI/2020/11/029284
• Lead Sponsor: SASTRA Deemed University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Males / females 18 or older

2.Patients with full-thickness traumatic wounds, surgical wounds, diabetic wounds, post-debridement wounds of 1 to 10 cm 2

3.Ulcer free of all necrotic and infected soft tissue (based on clinical investigatorâ??s discretion).

4.Have no significant diseases or clinically significant abnormal laboratory values during screening

5.In case of diabetic subjects, with regular medical treatment for diabetes

6.Able to understand, communicate and sign the written informed consent form

7.Adequate hematology, biochemistry & urine laboratory values

Exclusion Criteria

Any of the following is regarded as a criterion for exclusion from the study:

1. Patients showing impaired blood coagulation

2.Patients with hematopoietic, renal, immunological and dermatological diseases/disorders

3.History of psychiatric disorders

4.Recent history ( < 2 years) of alcoholism (alcohol abuse) or unlikely to refrain from excessive alcohol consumption during the study period

5.Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period

6.Use of any recreational drugs or a history of drug addiction

7.Participation in another trial within 30 days of enrollment for this study

8.Women who are pregnant or are breast feeding

9.Subjects with positive HIV, HBV and HCV

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency and severity of all treatment-related adverse events, during and after use of PHBV nanofibrous scaffold will be examined throughout the follow-up period. Adverse events will be assessed on a continuous basisTimepoint: 1 week, 2 weeks, 3 weeks, 4, weeks, 5 weeks and 6 weeks post-implantation

Secondary Outcome Measures

Name	Time	Method
Wound closureTimepoint: The treatment period of each subject will be 6 weeks and follow up period of 5 weeks