| CTRI Number |
CTRI/2024/09/073751 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A RCT to evaluate the role of absorbable antimicrobial sutures in comparison to conventional sutures in the prevention of SSI |
|
Scientific Title of Study
|
A Randomized control trial to evaluate the role of absorbable antimicrobial sutures in comparison to conventional sutures in the prevention of surgical site infections |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Tripathi |
| Designation |
Junior Resident |
| Affiliation |
UPUMS Saifai |
| Address |
Department of General Surgery
Room N0 408
Rani Lakshmi Bai Hostel
UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
07579210880 |
| Fax |
|
| Email |
soumya.trp.95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Somendra Pal Singh |
| Designation |
Professor |
| Affiliation |
UPUMS Saifai |
| Address |
Department of General Surgery UPUMS Saifai
Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9719101511 |
| Fax |
|
| Email |
somendrachauhan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Tripathi |
| Designation |
Junior Resident |
| Affiliation |
UPUMS Saifai |
| Address |
Department of General Surgery
Room N0 408
Rani Lakshmi Bai Hostel
UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
07579210880 |
| Fax |
|
| Email |
soumya.trp.95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
UPUMS Saifai
Etawah |
|
|
Primary Sponsor
|
| Name |
UPUMS Saifai |
| Address |
Department of General Surgery
Uttar Pradesh University of Medical Sciences Saifai
Etawah Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Soumya Tripathi |
Uttar Pradesh University of Medical Sciences Saifai Etawah Saifai |
Department of General Surgery
Uttar Pradesh University of Medical Sciences Saifai Etawah
Etawah
UTTAR PRADESH |
7579210880
soumya.trp.95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L763||Postprocedural hematoma and seromaof skin and subcutaneous tissue following a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Absorbable Suture |
Polydioxanone Suture will be used to close the abdominal wall |
| Intervention |
Antimicrobial Coated Absorbable Suture |
Triclosan-coated polyglactin 910 sutures will be used to close abdominal wall at the time of surgery and will be followed up for 30 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
• Adult patients (≥18 years) undergoing surgery at the participating hospital
• Elective abdominal surgeries (Open abdominal surgery is defined as surgically opened peritoneal cavity.
• Ability to provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Bowel/Gastric Perforation
2. Any drug, alcohol, or nicotine abuse – People with mental disorders
3. Participants under 18 years
4.Emergency surgery/procedures
5.Not willing to participate in the study)
• Pregnant or breastfeeding women
• Immunocompromised patients
• Patients with known hypersensitivity to any of the components of the suture material
• Patients with a pre-existing infection at the surgical site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Surgical Site Infection within 30 days post surgery |
Incidence of Surgical Site Infection within 30 days post surgery at 7thDay, 15th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Evaluate the safety profile:
The trial also aims to assess the safety profile of absorbable antimicrobial sutures compared to standard absorbable sutures. This includes monitoring for any adverse events or complications associated with the use of antimicrobial sutures, such as allergic reactions or tissue irritation.
• Assess wound healing:
The study may include an evaluation of wound healing outcomes between the two suture groups. This could involve monitoring wound closure, presence of wound complications (e.g., dehiscence), and overall wound healing progression.
• Compare surgical outcomes:
The trial will investigate other surgical outcomes related to the use of absorbable antimicrobial sutures, such as surgical site complications (e.g., seroma formation, hematoma), length of hospital stay, or the need for additional surgical interventions.
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Surgical site infections (SSI) are a risk inherent to surgical procedures and a frequent complication, notably after digestive surgery. SSI are associated with severe morbidity and mortality, especially in high-risk patient populations. • •The cornerstones for reducing the risk of SSI include exquisite surgical technique, timely and appropriate antimicrobial prophylaxis [5], effective and persistent skin antisepsis, and identification of adjunctive strategies for reducing wound contamination [6] and promoting wound healing. • •Various bacteria may contaminate not only the tissue in a surgical wound but also the actual suture material. • •If the surgical suture is implicated as the cause of a wound infection, then an antimicrobial coating should nearly eliminate the possibility of the suture material becoming a vector of infection. |