This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (\< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.
This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Laparotomy closure with Duramesh
Laparotomy closure with standard PDS
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
RECRUITINGThe primary outcome is SSE that occurs within 1 month after surgery.
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (\< 1 month). SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other
Time frame: 1 month
SSE within the first 12 months after repair.
SSE include: Surgical incision wound (this does NOT include a less than 5 mm scar-related superficial wound due to scar instability), Chronic draining sinus, Enterocutaneous fistula, Persistent seroma or fluid collection between the abdominal wall incision and the skin but not draining, Other
Time frame: 12 months
Clinical hernia occurrence/recurrence within 12 months after repair.
This study is intended to demonstrate Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.
Time frame: 12 months
Return to the operating room (re-interventions) within 12 months for device related issue.
Re-interventions are defined as: All re-interventions relating to abdominal wall closure complications or abdominal re-exploration.
Time frame: 12 months
Surgeon satisfaction at index-procedure using the 5-point smiley face scale.
Time frame: Procedure
Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Technical success of index-procedure.
Technical success is defined as successful abdominal wall closure without unexpected difficulties.
Time frame: Procedure
Device performance using the 5-point smiley face scale.
Time frame: Procedure
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.
The pain NRS is a single 11-point numeric scale with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondents selects a whole number (0 to 10 integers) that best reflects the intensity of their pain. Pain will be scored in rest and with activity. Activity is defined as activity of daily living, e.g. walking, driving, getting into a car, setting the dinner table, doing the laundry, etc.
Time frame: 1 month
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.
The pain NRS is a single 11-point numeric scale with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondents selects a whole number (0 to 10 integers) that best reflects the intensity of their pain. Pain will be scored in rest and with activity. Activity is defined as activity of daily living, e.g. walking, driving, getting into a car, setting the dinner table, doing the laundry, etc.
Time frame: 12 months
Palpability/sensation of suture used for the repair at 12-months follow-up.
Assessment whether the patient can feel the suture.
Time frame: 12 months
Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.
The SF-12 Health Survey is a 12-item, patient-reported survey of patient health.
Time frame: 12 months
Patient satisfaction at 1-month follow-up 5-point smiley face scale.
Time frame: 1 month
Patient satisfaction at 12-months follow-up 5-point smiley face scale.
Time frame: 12 months