| CTRI Number |
CTRI/2021/07/034509 [Registered on: 01/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study to evaluate the safety and performance of an anti-bacterial wound dressing |
|
Scientific Title of Study
|
Prospective, international, multicenter, observational study to evaluate the
clinical performance and safety of a DACC-impregnated
transparent postoperative dressing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hardy Schweigel |
| Designation |
Clinical Trial Manager |
| Affiliation |
Global Clinical Affairs |
| Address |
Essity India Private Limited
9th Floor, E- Wing, Unit No. 901-902,
Lotus Corporate Park, Laxmi Nagar,
Goregaon (East), Mumbai 400 063
Maharashtra, India
BSN medical GmbH an essity company
Schuetzenstrasse 1-3
22761 Hamburg
Germany
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
004915227752954 |
| Fax |
|
| Email |
hardy.schweigel@essity.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hardy Schweigel |
| Designation |
Clinical Trial Manager |
| Affiliation |
Global Clinical Affairs |
| Address |
Essity India Private Limited
9th Floor, E- Wing, Unit No. 901-902,
Lotus Corporate Park, Laxmi Nagar,
Goregaon (East), Mumbai 400 063
Maharashtra, India
BSN medical GmbH an essity company
Schuetzenstrasse 1-3
22761 Hamburg
Germany
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
004915227752954 |
| Fax |
|
| Email |
hardy.schweigel@essity.com |
|
Details of Contact Person
Public Query
|
| Name |
Hardy Schweigel |
| Designation |
Clinical Trial Manager |
| Affiliation |
Global Clinical Affairs |
| Address |
Essity India Private Limited
9th Floor, E- Wing, Unit No. 901-902,
Lotus Corporate Park, Laxmi Nagar,
Goregaon (East), Mumbai 400 063
Maharashtra, India
BSN medical GmbH an essity company
Schuetzenstrasse 1-3
22761 Hamburg
Germany
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
004915227752954 |
| Fax |
|
| Email |
hardy.schweigel@essity.com |
|
|
Source of Monetary or Material Support
|
| Essity India Private Limited |
|
|
Primary Sponsor
|
| Name |
Essity India Private Limited |
| Address |
9th Floor, E- Wing, Unit No. 901-902,
Lotus Corporate Park, Laxmi Nagar,
Goregaon (East), Mumbai 400 063
Maharashtra, India |
| Type of Sponsor |
Other [medical device industry - global] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G V Rao |
AIG Hospitals |
Surgical Gastroenterology Department
No 136, Plot No 2/3/4/5 Survey, 1, Mindspace Rd, Gachibowli, Telangana 500032, India
Hyderabad
TELANGANA |
009167444222
info@aighospitals.com |
| Dr Navaladi Shankar |
Apollo Hospitals |
Department of Orthopedics
Greams Road, No: 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu 600006, India
Chennai
TAMIL NADU |
00914428293333
info@apollohospitals.com |
| Dr Parag Sancheti |
Sancheti Hospital |
Institute for Orthopedic and Rehabilitation
11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra, India
Pune
MAHARASHTRA |
00919822353333
parag@sanchetihospital.org |
| Dr Gurava Reddy |
Sunshine Hospitals |
Department for Orthopedics
Sunshine Hospitals, PG Road, Opposite Parsi Dharamsala, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad, Telangana 500003, India
Hyderabad
TELANGANA |
00914044550000
info@sunshinehospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Apollo Hospitals |
Approved |
| Institutional Ethics Committee – Asian Institute of Gastroenterology, India |
Approved |
| Institutional Ethics Committee Sancheti Institute |
Approved |
| Sunshine institutional ethics committee, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective:
ï‚· Incidence of superficial and deep surgical site infections after 5
to 7 days
Secondary objectives:
ï‚· Incidence of superficial and deep surgical site infections after 14
and 30 days |
baseline, 7 days post-surgery, 14 days post-surgery and 30 days postsurgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ï‚· Incidence of superficial and deep surgical site infections
Type of surgical procedure
ï‚· Skin damage after dressing removal
ï‚· Pain at dressing removal
ï‚· Signs of infection
ï‚· Wound condition
ï‚· Condition of peri-wound skin
ï‚· Dressing adhesion
ï‚· Patient satisfaction
ï‚· Wound care giver satisfaction |
7 days post-surgery, 14 days post-surgery and 30 days postsurgery |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2021 |
| Date of Study Completion (India) |
26/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/02/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |