Clinical trial NCT02431039: Comparison Between NEOSORB Plus and NEOSORB
Official title: Comparison of Intraoperative Handling and Wound Healing Between NEOSORB Plus Antibacterial Suture With NEOSORB Suture: Prospective, Single-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Reaction to Suture Material
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Collaborating Center, Seoul, Korea
name: Korea Health Industry Development Institute
name: Samyang Biopharmaceuticals Corporation
First posted: 2015-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall handling
timeFrame: During the operation
Secondary outcomes:
measure: Ease of passage though tissue
timeFrame: During the operation
measure: First-throw knot holding
timeFrame: During the operation
measure: Knot tie-down smoothness
timeFrame: During the operation
measure: Knot security
timeFrame: During the operation
measure: Surgical hand
timeFrame: During the operation
measure: Memory
timeFrame: During the operation
measure: Lack of fraying
timeFrame: During the operation
measure: Healing progress, apposition
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: Infection
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: Seroma requiring drainage
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: Suture sinus, culture-negative
timeFrame: On postoperative 1st and 11(± 4)th day
measure: Erythema
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: Edema
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: Pain
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: Skin temperative increase
timeFrame: On postoperative 1st(+1) and 11th(±4) day
measure: 30 days cumulative skin infection rate
timeFrame: Within postoperative 30 days
measure: 30 days cumulative seroma requiring drainage rate
timeFrame: Within postoperative 30 days
measure: 30 days cumulative suture sinus (culture-negative) rate
timeFrame: Within postoperative 30 days
measure: Adverse events
timeFrame: Within postoperative 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.