Comparison Between NEOSORB Plus and NEOSORB

August 12, 2015 updated by: Chang Wook Jeong, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Detailed Description

  1. Enrollment

    1. Urologic surgery which needs fascia and subcutaneous tissue repairs
    2. Clean and clean-contaminated surgery
    3. Patients aged more than 18 years and under 80 years
  2. Randomization

    1. NEOSORB Plus (chlorhexidine diacetate coated PGLA910) or NEOSORB (PGLA910) suture
    2. Stratification by operative methods: Open surgery vs. laparoscopic or robot-assisted laparoscopic surgery
  3. Follow-up with 30 days

    1. Primary endpoint: intraoperative handling during operation
    2. Secondary endpoint: wound healing assessment on postoperative 1st (+1) days and 11th (± 4) days
    3. Safety evaluation: counting adverse events within postoperative 30 days

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEOSORB PLUS
Subjects who are treated by NEOSORB PLUS
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
Other Names:
  • Antibacterial suture material
Active Comparator: NEOSORB
Subjects who are treated by NEOSORB
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Other Names:
  • Non-antibacterial suture material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall handling
Time Frame: During the operation
1 to 5 scale
During the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of passage though tissue
Time Frame: During the operation
1 to 5 scale
During the operation
First-throw knot holding
Time Frame: During the operation
1 to 5 scale
During the operation
Knot tie-down smoothness
Time Frame: During the operation
1 to 5 scale
During the operation
Knot security
Time Frame: During the operation
1 to 5 scale
During the operation
Surgical hand
Time Frame: During the operation
1 to 5 scale
During the operation
Memory
Time Frame: During the operation
1 to 5 scale
During the operation
Lack of fraying
Time Frame: During the operation
1 to 5 scale
During the operation
Healing progress, apposition
Time Frame: On postoperative 1st(+1) and 11th(±4) day
Complete vs. Incomplete
On postoperative 1st(+1) and 11th(±4) day
Infection
Time Frame: On postoperative 1st(+1) and 11th(±4) day
No vs. YES
On postoperative 1st(+1) and 11th(±4) day
Seroma requiring drainage
Time Frame: On postoperative 1st(+1) and 11th(±4) day
No vs. YES
On postoperative 1st(+1) and 11th(±4) day
Suture sinus, culture-negative
Time Frame: On postoperative 1st and 11(± 4)th day
No vs. YES
On postoperative 1st and 11(± 4)th day
Erythema
Time Frame: On postoperative 1st(+1) and 11th(±4) day
0, + (closure line redness), ++(redness<2mm), +++ (redness>2mm)
On postoperative 1st(+1) and 11th(±4) day
Edema
Time Frame: On postoperative 1st(+1) and 11th(±4) day
0, + (slight increase in firmness), ++(skin dimples with pressure), +++ (tense firmness)
On postoperative 1st(+1) and 11th(±4) day
Pain
Time Frame: On postoperative 1st(+1) and 11th(±4) day
0, + (with pressure), ++(with touching), +++ (constant)
On postoperative 1st(+1) and 11th(±4) day
Skin temperative increase
Time Frame: On postoperative 1st(+1) and 11th(±4) day
0, + (slight), ++(definite), +++ (hot, radiating)
On postoperative 1st(+1) and 11th(±4) day
30 days cumulative skin infection rate
Time Frame: Within postoperative 30 days
No vs. YES
Within postoperative 30 days
30 days cumulative seroma requiring drainage rate
Time Frame: Within postoperative 30 days
No vs. YES
Within postoperative 30 days
30 days cumulative suture sinus (culture-negative) rate
Time Frame: Within postoperative 30 days
No vs. YES
Within postoperative 30 days
Adverse events
Time Frame: Within postoperative 30 days
Within postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chang Wook Jeong, M.D.,Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 26, 2015

First Submitted That Met QC Criteria

April 26, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-1503-016-653

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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