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Effectiveness Of Theruptor Surgical Wound Dressing in Patients who are undergoing Abdominal and Joint surgeries.

Phase 3
Completed
Conditions
Health Condition 1: T814- Infection following a procedure
Registration Number
CTRI/2022/03/040898
Lead Sponsor
CareNow Medical Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
210
Inclusion Criteria

1. Male or female of age 18 years or older.

2. Patient is willing to provide informed consent and is willing to participate

in all procedures and follow up evaluations necessary to complete the study.

3. Patients undergoing elective abdominal surgery/elective c-section

surgery/elective Joint surgery

Exclusion Criteria

1. Patients with severe anemia - Hgb < 10 g/dL (males) or < 9 g/dL (females)

2. Patients with severe malnutrition (Albumin < 3.0 gm/dl; > 10% weight loss in preceding 4 weeks)

3. Patients with serum Creatinine more than 2 mg/dl

4. HbA1c more than 10% Patients with primary peritonitis and liver cirrhosis.

5.Patient who are taking medications that are considered immune system modulator.

6.Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture).Wounds in which deep closure could not be achieved

7. Allergy to the test or comparator products employed in the study.

8. Wounds in which hemostasis is not able to be achieved, eg, drain is placed or Warfarin PT- INR level >2.5 prior to surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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