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OpenTrials
Completed

NCT Number: NCT02431039

Comparison Between NEOSORB Plus and NEOSORB

This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of intraoperative handling.

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Key information

Conditions

Skin Reaction to Suture Material

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

  • Enrollment
  • Urologic surgery which needs fascia and subcutaneous tissue repairs
  • Clean and clean-contaminated surgery
  • Patients aged more than 18 years and under 80 years
  • Randomization
  • NEOSORB Plus (chlorhexidine diacetate coated PGLA910) or NEOSORB (PGLA910) suture
  • Stratification by operative methods: Open surgery vs. laparoscopic or robot-assisted laparoscopic surgery
  • Follow-up with 30 days
  • Primary endpoint: intraoperative handling during operation
  • Secondary endpoint: wound healing assessment on postoperative 1st (+1) days and 11th (± 4) days
  • Safety evaluation: counting adverse events within postoperative 30 days

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Urologic surgery which needs fascia and subcutaneous tissue repairs
  • Clean and clean-contaminated surgery

Exclusion criteria

  • Contaminated surgery
  • Wound requiring retention suture
  • Suspicious malnutrition status
  • Active infection status or AIDS
  • Incision sites prone to expand, stretch, distend, or require support
  • Allergy or hypersensitivity to chlorhexidine diacetate
  • Significant active medical illness which in the opinion of the investigator would preclude protocol treatment

Treatment and study plan

NEOSORB PLUS

Device

Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)

Other names: Antibacterial suture material

NEOSORB

Device

Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)

Other names: Non-antibacterial suture material

Primary outcomes

  1. Overall handling

    Time frame: During the operation

    1 to 5 scale

Secondary outcomes

  1. Ease of passage though tissue

    Time frame: During the operation

    1 to 5 scale

  2. First-throw knot holding

    Time frame: During the operation

    1 to 5 scale

  3. Knot tie-down smoothness

    Time frame: During the operation

    1 to 5 scale

  4. Knot security

    Time frame: During the operation

    1 to 5 scale

  5. Surgical hand

    Time frame: During the operation

    1 to 5 scale

  6. Memory

    Time frame: During the operation

    1 to 5 scale

  7. Lack of fraying

    Time frame: During the operation

    1 to 5 scale

  8. Healing progress, apposition

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    Complete vs. Incomplete

  9. Infection

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    No vs. YES

  10. Seroma requiring drainage

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    No vs. YES

  11. Suture sinus, culture-negative

    Time frame: On postoperative 1st and 11(± 4)th day

    No vs. YES

  12. Erythema

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    0, + (closure line redness), ++(redness<2mm), +++ (redness>2mm)

  13. Edema

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    0, + (slight increase in firmness), ++(skin dimples with pressure), +++ (tense firmness)

  14. Pain

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    0, + (with pressure), ++(with touching), +++ (constant)

  15. Skin temperative increase

    Time frame: On postoperative 1st(+1) and 11th(±4) day

    0, + (slight), ++(definite), +++ (hot, radiating)

  16. 30 days cumulative skin infection rate

    Time frame: Within postoperative 30 days

    No vs. YES

  17. 30 days cumulative seroma requiring drainage rate

    Time frame: Within postoperative 30 days

    No vs. YES

  18. 30 days cumulative suture sinus (culture-negative) rate

    Time frame: Within postoperative 30 days

    No vs. YES

  19. Adverse events

    Time frame: Within postoperative 30 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea Health Industry Development Institute
  • Medical Research Collaborating Center, Seoul, Korea
  • Samyang Biopharmaceuticals Corporation

Registry information

Official study title

Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2015
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.