Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure

Conditions
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Laparotomy Closure After Abdominal Surgery

Intervention / Treatment
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* Device: Duramesh
* Device: Polydioxanone suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigator-initiated, academic, prospective, randomized-controlled, interventional, monocenter study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Duramesh<br>Laparotomy closure is associated with the occurrence of Surgical Site Events (SSEs) such as wound dehiscence and incisional hernias. Abdominal wall closure can also cause pain and discomfort, or can lead to intestinal obstruction. Standard sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge leading to repair failure. Meshes distribute forces and allow for tissue ingrowth. Duramesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's first device that both approximates tissue and allows ingrowth for a strong early repair. Consequently, the expected clinical benefit is the reduced occurrence of Surgical Site Events such as incisional hernias. Additional benefits may include reduced pain and improved quality of life due to durable closure of the abdominal wall with Duramesh. This will be evaluated in this randomized study. Size 1 Duramesh is used in this RCT. Duramesh is CE-marked. | Device: Duramesh<br>* Laparotomy closure with Duramesh<br>|
| Other: Standard suture<br>2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator. | Device: Polydioxanone suture<br>* Laparotomy closure with standard PDS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 12 months | 
| Surgeon satisfaction at index-procedure using the 5-point smiley face scale. |  | Procedure | 
| Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale. |  | 1 month | 
| Technical success of index-procedure. | Technical success is defined as successful abdominal wall closure without unexpected difficulties. | Procedure | 
| Device performance using the 5-point smiley face scale. |  | 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. | 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. | 12 months | 
| Palpability/sensation of suture used for the repair at 12-months follow-up. | Assessment whether the patient can feel the suture. | 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. | 12 months | 
| 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 |