Gynecologic Disease
Conditions
Brief summary
Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.
Interventions
DEVICEBarbed PDS suture (STRATAFIX Symmetric PDS Plus)
STRATAFIX Symmetric PDS Plus is a barbed suture.
DEVICENon-barbed PDS suture (PDS Plus)
Non-barbed suture
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
2\*2 factorial design Primary randomization: Barbed suture vs. Non-barbed suture in fascia closure Secondary randomization: subcutaneous drain insertion vs. non-insertion The effect of secondary randomization is one of secondary objectives.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Anticipating midline laparotomy for gynecologic diseases * ECOG performance status 0 - 2
Exclusion criteria
* Previous or current abdominal incisional hernia * Pregnant * Previous radiation on abdomen area * Allergy to PDS or irgacare MP * Having disease affecting wound healing such as uncontrolled DM, autoimmune vasculitis, liver cirrhosis, coagulopathy * BMI \> 35 * Current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible) * Abdominal midline laparotomy within 6 months * Surgery for infection control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of incisional hernia | from surgery to 1 year | Incisional hernia till 1 year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of surgical site infection | from surgery to 4weeks | — |
| Incidence of wound dehiscence | post-surgery 4weeks | — |
| Time-event curve of incisional hernia | from surgery to 1 year | — |
| Treatment related adverse event | from surgery to 1 year | — |
| NRS | from surgery to postoperative 4 day | pain captured by NRS in nursing record, 0-10, higher score means more pain |
| Brief Pain Inventory - Korean (BPI-K) score | Baseline, postoperative day 2, 4 | Pain measured with BPI-K Specifically score (0-10 all domain, higher score mean worse outcome) in domain of worst pain, least pain, average pain, current pain, impact of pain in general activity, mood, work, relationship, ambulation, sleep and happiness |
Contacts
Primary ContactKidong Kim
Outcome results
None listed