Observational study to evaluate the safety and performance of an anti-bacterial wound dressing

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/07/034509
• Lead Sponsor: Essity India Private Limited

Brief Summary

The primary purpose of this clinical study is the evaluation of clinical performance to reduce surgical site infections in gastrointestinal and orthopedic surgeries and the safety of the dressing. Further, data on wearing comfort, product handling, pain during removal and quality of life are considered as secondary outcomes. The products will be used as part of routine wound care within the scope of their intended purpose without any additional invasive or burdensome examination. Subjects undergoing orthopedical or gastroenterology surgery will be recruited in several hospitals in India and use of dressing will be documented for four weeks at four study visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Study Completion: 2022-02-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.Signed informed consent to participate in this study 2.Men, women or diverse 3.≥ 18 years of age 4.Patient is mentally and physically able to participate in this study 5.Wound from gastrointestinal or orthopaedical surgeries indicated for treatment with the investigational products for a time period of 14 days.

Exclusion Criteria

1.Infection of the target wound 2.Patients actively taking antibiotics for other conditions up to the day of surgery (not including surgical prophylaxis or antibiotic use related to the index procedure) 3.Subjects require placement of external fixators 4.Any drug addiction including alcohol 5.Known sensitivity or allergy to any component of the study product 6.Patients who participate in any other clinical study investigating drugs or medical devices 7.Patients not willing to attend at follow-up visits 8.Patients not able to give consent 9.Pregnant or breastfeeding patients.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective:	baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery
ï‚· Incidence of superficial and deep surgical site infections after 5	baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery
to 7 days	baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery
Secondary objectives:	baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery
ï‚· Incidence of superficial and deep surgical site infections after 14	baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery
and 30 days	baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery

Secondary Outcome Measures

Name	Time	Method
ï‚· Incidence of superficial and deep surgical site infections	Type of surgical procedure

Trial Locations

Locations (4)

AIG Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Apollo Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Sancheti Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Sunshine Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

AIG Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr G V Rao

Principal investigator

009167444222

info@aighospitals.com