Comparison of adhesive and suture in skin closure following small incision abdominal surgery (laparoscopic)

A comparative study to assess efficacy and safety of suturing versus topical skin adhesive (n-butyl-2-cyanoacrylate) for portsite skin closure in patients undergoing laparoscopic surgery in a tertiary care hospital - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070591

Enrollment

Registered

2024-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: N-butyl-2-Cynoacrylate: Topical tissue adhesive for closure of portsite after laparoscopic surgery Control Intervention1: Triclosan coated polyglactin 910: Antimicrobial coated polyglac

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to give written informed consent 2. Patients planned for total laparoscopic surgery in the Department of Obstetrics and Gynecology 3. Patients posted for Fibroid, Unresponsive perimenopausal hemorrhage, Adenomyosis, Perimenopausal women with AUB laparoscopic surgeries

Exclusion criteria

Exclusion criteria: 1. Known or suspected gynecological malignancy 2. Patients with active pelvic infection 3. Patients with cardio-pulmonary complications 4. Patients unfit for pneumo-peritoneum or Trendelenburg position 5. Patient with known Coagulation disorder 6. Patients who have not given written informed consent

Design outcomes

Primary

Measure	Time frame
To evaluate incidence of surgical site infection using CDC criteria for SSITimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7	—

Secondary

Measure	Time frame
To assess Cosmetic appearance of the wound using Modified Hollander Wound ScoreTimepoint: Day of discharge Post-surgery day 30±7;To assess the time required for port closure in both the groupsTimepoint: Day of surgery;To evaluate adverse events among the two groupsTimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7;To Evaluate ease of application/usage using Product Usage Assessment Scale (using 5-point scale, with 5 being excellent and 1 being poor)Timepoint: Day of surgery;To Evaluate patient’s satisfaction in both the groups (using 5-point scale, with 5 being excellent and 1 being poor)Timepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7;To evaluate post-operative wound complications in both the groupsTimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7;To evaluate wound pain using 10-point Visual Analog Scale (VAS) scoreTimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7	—

Measure

Time frame

To assess Cosmetic appearance of the wound using Modified Hollander Wound ScoreTimepoint: Day of discharge Post-surgery day 30±7;To assess the time required for port closure in both the groupsTimepoint: Day of surgery;To evaluate adverse events among the two groupsTimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7;To Evaluate ease of application/usage using Product Usage Assessment Scale (using 5-point scale, with 5 being excellent and 1 being poor)Timepoint: Day of surgery;To Evaluate patient’s satisfaction in both the groups (using 5-point scale, with 5 being excellent and 1 being poor)Timepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7;To evaluate post-operative wound complications in both the groupsTimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7;To evaluate wound pain using 10-point Visual Analog Scale (VAS) scoreTimepoint: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7

—

Countries

India

Contacts

Public ContactDr Mahendra G G

Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara

drmuba@gmail.com9964026610

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026