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Clinical Trials/CTRI/2020/11/029284
CTRI/2020/11/029284
Not yet recruiting
Phase 1

A single center, open labeled, pilot study to evaluate the safety and efficacy of Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanofibrous synthetic biodegradable skin graft for full-thickness wounds

SASTRA Deemed University0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: T758- Other specified effects of external causes

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: T758- Other specified effects of external causes
Sponsor
SASTRA Deemed University
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
SASTRA Deemed University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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