Laparotomy Closure After Abdominal Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDuramesh
Laparotomy closure with Duramesh
DEVICEPolydioxanone suture
Laparotomy closure with standard PDS
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Investigator-initiated, academic, prospective, randomized-controlled, interventional, monocenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or greater * Abdominal laparotomy 5 cm in length or greater, either midline or non-midline * Isolated ostomy site takedown with or without parastomal hernia * Patient accepts participation and gives informed consent * Patient and investigator signed and dated the informed consent form prior to the index-procedure
Exclusion criteria
* Pregnancy * Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia \< 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion) * Prior hernia repair at laparotomy site * Use of planar mesh in addition to sutures for closure * CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open * Life expectancy less than 1 year * Patient is unable / unwilling to provide informed consent * Patient is unable to comply with the protocol or proposed follow-up visits * Patient is enrolled in another abdominal wall study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is SSE that occurs within 1 month after surgery. | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSE within the first 12 months after repair. | 12 months | 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 |
| Clinical hernia occurrence/recurrence within 12 months after repair. | 12 months | This study is intended to demonstrate Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure. |
| Return to the operating room (re-interventions) within 12 months for device related issue. | 12 months | Re-interventions are defined as: All re-interventions relating to abdominal wall closure complications or abdominal re-exploration. |
| Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale. | 1 month | — |
| Technical success of index-procedure. | Procedure | Technical success is defined as successful abdominal wall closure without unexpected difficulties. |
| Device performance using the 5-point smiley face scale. | Procedure | — |
| Surgeon satisfaction at index-procedure using the 5-point smiley face scale. | Procedure | — |
| Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up. | 12 months | 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. |
| Palpability/sensation of suture used for the repair at 12-months follow-up. | 12 months | Assessment whether the patient can feel the suture. |
| Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up. | 12 months | The SF-12 Health Survey is a 12-item, patient-reported survey of patient health. |
| Patient satisfaction at 1-month follow-up 5-point smiley face scale. | 1 month | — |
| Patient satisfaction at 12-months follow-up 5-point smiley face scale. | 12 months | — |
| Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up. | 1 month | 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. |
Countries
Belgium
Contacts
Primary ContactDorien Haesen, PhD
Outcome results
None listed