A study comparing two brands of similar suture materials (TrulonÃ?Â® and EthilonÃ?Â® polyamide suture), for closure of the skin following open abdominal surgeries

Single blind, randomized study comparing clinical equivalence of TrulonÃ?Â® and EthilonÃ?Â® polyamide sutures, for closure of the skin following laparotomy incisions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027978

Enrollment

104

Registered

2020-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery Health Condition 2: N859- Noninflammatory disorder of uterus, unspecified

Interventions

Intervention1: TrulonÃ?Â® suture: TrulonÃ?Â® (Healthium) suture is a polyamide (nylon) non-absorbable, sterile surgical suture, which will be removed 7-14 days after suturing. Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Women with BMI >30 Kg/m2 2. Women with hemoglobin levels 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

Design outcomes

Primary

Measure	Time frame
1. To compare the rate of wound infection with Trulon (Healthium) and Ethilon (J & J) polyamide suturesTimepoint: Day 3, Day 7-14, Week 6 and Week 12	—

Secondary

Measure	Time frame
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 suturesTimepoint: Day 3, Day 7-14, Week 6 and Week 12	—

Measure

Time frame

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 suturesTimepoint: Day 3, Day 7-14, Week 6 and Week 12

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Countries

India

Contacts

Public ContactDr Ashok Kumar Moharana

Healthium Medtech Pvt.Ltd.

ashok.m@healthiummedtech.com9717887751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026