Skin Reaction to Suture MaterialPhase 2NCT02431039
Comparison Between NEOSORB Plus and NEOSORB
A Phase 2 study testing NEOSORB PLUS and NEOSORB in people with Skin Reaction to Suture Material, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Skin Reaction to Suture Material
- What is being tested?
- NEOSORB PLUS and NEOSORB
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urologic surgery which needs fascia and subcutaneous tissue repairs
- Clean and clean-contaminated surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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
- Conditions
- Skin Reaction to Suture Material
- Being tested
- NEOSORB PLUS, NEOSORB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEOSORB PLUSDevice
Also called Antibacterial suture material
Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
NEOSORBDevice
Also called Non-antibacterial suture material
Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
| Study group | Role | What they receive |
|---|---|---|
| NEOSORB PLUS | Experimental | Subjects who are treated by NEOSORB PLUS Receives: Device: NEOSORB PLUS |
| NEOSORB | Active comparator | Subjects who are treated by NEOSORB Receives: Device: NEOSORB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall handling
1 to 5 scale
Measured: During the operation
Secondary outcomes (19)
Ease of passage though tissue
1 to 5 scale
Measured: During the operation
First-throw knot holding
1 to 5 scale
Measured: During the operation
Knot tie-down smoothness
1 to 5 scale
Measured: During the operation
Knot security
1 to 5 scale
Measured: During the operation
Surgical hand
1 to 5 scale
Measured: During the operation
Memory
1 to 5 scale
Measured: During the operation
Lack of fraying
1 to 5 scale
Measured: During the operation
Healing progress, apposition
Complete vs. Incomplete
Measured: On postoperative 1st(+1) and 11th(±4) day
Infection
No vs. YES
Measured: On postoperative 1st(+1) and 11th(±4) day
Seroma requiring drainage
No vs. YES
Measured: On postoperative 1st(+1) and 11th(±4) day
Suture sinus, culture-negative
No vs. YES
Measured: On postoperative 1st and 11(± 4)th day
Erythema
0, + (closure line redness), ++(redness<2mm), +++ (redness>2mm)
Measured: On postoperative 1st(+1) and 11th(±4) day
Edema
0, + (slight increase in firmness), ++(skin dimples with pressure), +++ (tense firmness)
Measured: On postoperative 1st(+1) and 11th(±4) day
Pain
0, + (with pressure), ++(with touching), +++ (constant)
Measured: On postoperative 1st(+1) and 11th(±4) day
Skin temperative increase
0, + (slight), ++(definite), +++ (hot, radiating)
Measured: On postoperative 1st(+1) and 11th(±4) day
30 days cumulative skin infection rate
No vs. YES
Measured: Within postoperative 30 days
30 days cumulative seroma requiring drainage rate
No vs. YES
Measured: Within postoperative 30 days
30 days cumulative suture sinus (culture-negative) rate
No vs. YES
Measured: Within postoperative 30 days
Adverse events
Measured: Within postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Reaction to Suture MaterialStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Collaborating Center, Seoul, Korea, Korea Health Industry Development Institute, Samyang Biopharmaceuticals Corporation
- Responsible party
- Principal investigator, Chang Wook Jeong, Seoul National University Hospital
- Investigators
- Chang Wook Jeong, M.D.,Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431039
- Sponsor's protocol ID
- D-1503-016-653
- Status last verified
- Aug 2015
- First submitted
- 26 Apr 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tae BS, Park JH, Kim JK, Ku JH, Kwak C, Kim HH, Jeong CW. Comparison of intraoperative handling and wound healing between (NEOSORB(R) plus) and coated polyglactin 910 suture (NEOSORB(R)): a prospective, single-blind, randomized controlled trial. BMC Surg. 2018 Jul 6;18(1):45. doi: 10.1186/s12893-018-0377-4.
PubMed 29980202
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02431039
- Acronym / sponsor ID
- D-1503-016-653
- Conditions
- Skin Reaction to Suture Material
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medical Research Collaborating Center, Seoul, Korea, Korea Health Industry Development Institute, Samyang Biopharmaceuticals Corporation
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEOSORB PLUS | Experimental | Device: NEOSORB PLUSSubjects who are treated by NEOSORB PLUS |
| NEOSORB | Active comparator | Device: NEOSORBSubjects who are treated by NEOSORB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urologic surgery which needs fascia and subcutaneous tissue repairs
- Clean and clean-contaminated surgery
Key exclusion criteria (7 listed)
- Contaminated surgery
- Wound requiring retention suture
- Suspicious malnutrition status
- Active infection status or AIDS
- Incision sites prone to expand, stretch, distend, or require support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEOSORB PLUSAlso: Antibacterial suture materialFascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910) | Device | NEOSORB PLUS |
| NEOSORBAlso: Non-antibacterial suture materialFascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910) | Device | NEOSORB |
Primary outcome
Overall handling
Time frame: During the operation
1 to 5 scale
19 secondary outcomes
Ease of passage though tissue
Time frame: During the operation
First-throw knot holding
Time frame: During the operation
Knot tie-down smoothness
Time frame: During the operation
Knot security
Time frame: During the operation
Surgical hand
Time frame: During the operation
Memory
Time frame: During the operation
Lack of fraying
Time frame: During the operation
Healing progress, apposition
Time frame: On postoperative 1st(+1) and 11th(±4) day
Infection
Time frame: On postoperative 1st(+1) and 11th(±4) day
Seroma requiring drainage
Time frame: On postoperative 1st(+1) and 11th(±4) day
Suture sinus, culture-negative
Time frame: On postoperative 1st and 11(± 4)th day
Erythema
Time frame: On postoperative 1st(+1) and 11th(±4) day
Edema
Time frame: On postoperative 1st(+1) and 11th(±4) day
Pain
Time frame: On postoperative 1st(+1) and 11th(±4) day
Skin temperative increase
Time frame: On postoperative 1st(+1) and 11th(±4) day
30 days cumulative skin infection rate
Time frame: Within postoperative 30 days
30 days cumulative seroma requiring drainage rate
Time frame: Within postoperative 30 days
30 days cumulative suture sinus (culture-negative) rate
Time frame: Within postoperative 30 days
Adverse events
Time frame: Within postoperative 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Derived from this study: PubMed 29980202Tae BS, Park JH, Kim JK, Ku JH, Kwak C, Kim HH, Jeong CW. Comparison of intraoperative handling and wound healing between (NEOSORB(R) plus) and coated polyglactin 910 suture (NEOSORB(R)): a prospective, single-blind, randomized controlled trial. BMC Surg. 2018 Jul 6;18(1):45. doi: 10.1186/s12893-018-0377-4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Wook Jeong, M.D.,Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NEOSORB PLUS and NEOSORB in people with Skin Reaction to Suture Material, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall handling (time frame: During the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015; AzTrials last refreshed its copy on 27 Oct 2026.