| CTRI Number |
CTRI/2020/09/027978 [Registered on: 23/09/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing two brands of similar suture materials (Trulon® and Ethilon® polyamide suture), for closure of the skin following open abdominal surgeries |
|
Scientific Title of Study
|
Single blind, randomized study comparing clinical equivalence of Trulon® and Ethilon® polyamide sutures, for closure of the skin following laparotomy incisions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IND-HEALTHIUM-TRULON-2020-07; V 2.0; Date:13 April 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Pvt.Ltd. |
| Address |
Healthium Medtech Pvt.Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Pvt.Ltd. |
| Address |
Healthium Medtech Pvt.Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Pvt.Ltd. |
| Address |
Healthium Medtech Pvt.Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech Pvt.Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore KARNATAKA 560058 India |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Pvt Ltd |
| Address |
Healthium Medtech Pvt.Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore KARNATAKA 560058 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Y Aruna Subha Shree Rao |
King George Hospital, Visakhapatnam |
Department of Obstetrics & Gynaecology, Maharani Peta, Viskhaptanam-530002
Visakhapatnam
ANDHRA PRADESH |
9866655515
arunay67@hotmail.com |
| Dr Padmasri R |
Sapthagiri Institute of Medical sciences & Research Center, Bengaluru |
Department of Obstetrics & Gynaecology,
# 15, Chikkasandra, Hesarghatta Main Road,
Bengaluru- 560090
Bangalore
KARNATAKA |
9620075477
drpadmasuraj@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam |
Approved |
| Institutional Ethics Committee, Sapthagiri Institute of Medical sciences & Research, Center Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ethilon® suture |
Ethilon® (Johnson & Johnson) suture is a polyamide (nylon) non-absorbable, sterile surgical suture, which will be removed 7-14 days after suturing. |
| Intervention |
Trulon® suture |
Trulon® (Healthium) suture is a polyamide (nylon) non-absorbable, sterile surgical suture, which will be removed 7-14 days after suturing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18 to 50 years, undergoing laparotomy-based obstetric/ gynecological procedures
2. Women with CDC surgical wound classification class I/II
3. Women with good systemic/ mental health as per opinion of investigator
4. Subjects who have given written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Women with BMI >30 Kg/m2
2. Women with hemoglobin levels <7g/dL
3. Women with a history of any laparotomy procedure or laparoscopic surgery
4. Women having urogenital tract infection within 2 weeks before the procedure
5. Women needing prophylactic mesh augmentation after laparotomy
6. Women undergoing elective/emergency laparoscopic abdominal surgeries
7. Women having active infection at or around the skin incision site
8. Women with history of allergy to nylon or similar products
9. Women already participating in another trial
10. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
11. Other indication-based exclusion, in opinion of investigator
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the rate of wound infection with Trulon (Healthium) and Ethilon (J & J) polyamide sutures |
Day 3, Day 7-14, Week 6 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate tissue reaction, wound dehiscence, skin disruptions, suture sinus, seroma, and hematoma
2. To assess overall intraoperative handling between two sutures
3. To assess the amount of time subject takes to return back to normal day to day activities
4. To evaluate material problems and other adverse events
5. To evaluate postoperative discomfort, pain and overall subject satisfaction score
6. To evaluate and compare the resultant scar and cosmetic effects of two sutures |
Day 3, Day 7-14, Week 6 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
21/01/2021 |
| Date of Study Completion (India) |
12/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The abdominal wall
surrounds the abdominal cavity, where many important organs are located.
Laparotomy is a surgical incision in the abdominal wall which is used to gain
access to the organs of the abdominal cavity. The abdominal wall has multiple
layers of tissues, with the skin as the outermost layer. The surgeon will close
these layers after completion of the procedure and abdominal skin closure is
the final step of surgical intervention. The two primary methods of skin
closure are with suture or staples. Sutures are more preferred to close the skin
because of their several benefits. Monofilament polyamide (nylon) sutures are
commonly used for closing the skin due to its low infectivity, satisfactory
wound tissue strength, even when used in infected wounds. In this study, we
plan to assess differences in the rate of post-operative complications after
skin closure, between two commonly used brands of non-absorbable polyamide
(nylon) sutures, Trulon® and Ethilon®.
|