Post Marketing clinical study on surgical wound dressing

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2020/06/026207

Lead Sponsor: Neosoteria Bandages Pvt Ltd

Brief Summary: This open label post marketing study is proposed to be conducted to evaluate the efficacy and safety of DRONAID dressing (Activated Charcoal Absorption Gauge) as compared to Saline Gauge Dressing on surgical wound

The study protocol will be reviewed and approved by Institutional Ethics Committee prior to the initiation of the trial at the Investigatorâ€™s Site.

50 subjects will be enrolled and randomized into two arms, in 1: 1 ratio. One arm will be getting Dronaid dressing and the other arm will be given Saline gauge. The subjects will be evaluated at the time of Inclusion in the study, subjects who undergo major/minor surgical procedures will be mainly included in the study. The subjects of both the gender between the age group of 18-60 yrs will be taken once they voluntarily sign the informed consent in front of the Principle Investigator.

Before applying the dressing over the wound, the wound will be evaluated by the Investigator as per the wound healing scale and if possible photograph will be taken as a baseline reading. Subjects Pain assessment will be conducted at the same time using VAS. At the baseline subjects vitals will also be recorded.

The subjects will be evaluated again at Day 3 for any adverse event or any complications. If the wound site or the dressing site shows any discharge the dressing will be changed as per the standardized norms and suitable measures will be taken as per the PI discretion.

The subjects will be subsequently recalled at Day 6and the wound site will be evaluated by the Investigator the dressing will be re applied if the wound area requires so as per PI discretion

At Day 15 (End of Study) the subjects will be recalled and the wound site will be evaluated by the Investigator using wound healing scale and Pain will also be recorded using VAS.

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Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

i)Subjects who are ready to give voluntary written informed consent.
ii)Both Male and female subjects between the age group of 18-60years iii)Subjects who undergone any major/ minor surgeries where the surgical wound need a dressing will be taken in to the study.

Exclusion Criteria

i)Subjects allergic to charcoal ii)Subjects who are unwilling to adhere to the study iii)Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i)The primary objective of this pilot study is to assess the efficacy of DRONAID (activated charcoal absorption gauge) over surgical wound.	i)The primary objective of this pilot study is to assess the efficacy of DRONAID (activated charcoal absorption gauge) over surgical wound at day 15 \| ii)Pain if any during the dressing change at day 15
ii)Pain if any during the dressing change at day 15	i)The primary objective of this pilot study is to assess the efficacy of DRONAID (activated charcoal absorption gauge) over surgical wound at day 15 \| ii)Pain if any during the dressing change at day 15

Secondary Outcome Measures

Name	Time	Method
i)The secondary objective is to evaluate the time taken for complete wound healing	Day 3,Day 6 and Day 15

Trial Locations

Locations (1): AIIMS Bhubaneswar
🇮🇳
Khordha, ORISSA, India
AIIMS Bhubaneswar
🇮🇳Khordha, ORISSA, India
Dr Pankaj
Principal investigator
9438884253
drpkushwaha@gmail.com