Clinical trials: Laparotomy
Pain, Postoperative
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy…
- Trial name
- MATRIX-2 (NCT02525133)
- Testing
- XaraColl
- Where
- 24 sites in United States
- Volunteers
- 319 people
- Sponsor
- Innocoll
Laparotomy, Suture; Complications, Mechanical
DuraMesh Laparotomy Study
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting.
- Conditions
- Laparotomy, Suture; Complications, Mechanical, Hernia Incisional
- Trial name
- NCT03966768
- Testing
- Duramesh suturable mesh for laparotomy closure, Conventional suture for laparotomy closure
- Sponsor
- Mesh Suture Inc.
Postoperative Ileus
A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly occurs in patients who have undergone abdominal surgery and contributes to postoperative morbidity, including delayed enteral…
- Trial name
- NCT00266461
- Testing
- Daikenchuto Extract Granules (TU-100)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Tsumura USA
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
Open Midline Laparotomy
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for…
- Trial name
- PREVENT (NCT03911700)
- Testing
- Phasix™ Mesh
- Where
- 32 sites in United States, Austria and 3 more
- Volunteers
- 477 people
- Sponsor
- C. R. Bard
Incisional Hernia
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
Interventional, prospective, multicenter, post-marketing clinical follow-up study. After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and…
- Trial name
- POETRY (NCT03912662)
- Testing
- Mesh augmented reinforcement
- Where
- 11 sites in France
- Volunteers
- 32 people
- Sponsor
- Medtronic - MITG
Abdominal Aortic Aneurysm, Morbid Obesity
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on…
- Trial name
- SSIHLVER (NCT06547138)
- Testing
- Prophylactic mesh
- Where
- 5 sites in Spain
- Volunteers
- 110 people
- Sponsor
- Aesculap AG
Primary Median Laparotomy
Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure
MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of…
- Trial name
- ISSAAC (NCT00572507)
- Testing
- MonoMax®
- Where
- 4 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Adhesions, Abdominal Cavity
A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
- Trial name
- A-PART (NCT00646412)
- Testing
- A-Part® Gel
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Ileus Postoperative
Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.
This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.
- Trial name
- ORE001PIIPOI (NCT05923086)
- Testing
- ORE001
- Where
- 3 sites in Germany
- Volunteers
- 126 people
- Sponsor
- Orexa BV
Hernia, Surgical Wound Dehiscence
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive…
- Trial name
- StAR (NCT01083472)
- Testing
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Where
- 29 sites in France, Germany and 4 more
- Volunteers
- 37 people
- Sponsor
- LifeCell
Injury of Abdominal Wall
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia.
- Trial name
- ESTOIH (NCT01965249)
- Testing
- Long stitch, Short Stitch
- Where
- 9 sites in Austria, Germany
- Volunteers
- 425 people
- Sponsor
- Aesculap AG
Laparotomy, Incisional Hernia
Clinical Performance and Safety of Suture-TOOL
The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Trial name
- NCT05695157
- Testing
- Suture-TOOL
- Where
- Sweden
- Volunteers
- 38 people
- Sponsor
- Suturion AB
Pain Control
Efficacy of Local Anesthetic Through Continuous Infusion
Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.
- Trial name
- NCT04173312
- Testing
- Bupivacaine infusion, Saline
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Ascension Health
Myoma
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove…
- Trial name
- NCT00562471
- Testing
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Angiotech Pharmaceuticals
Scars
MF-4181 for the Reduction of Scars Secondary to Abdominoplasty or Laparoscopy/Laparotomy Gynecologic Procedures
The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a hydrogel scaffold, in improving scars and their resulting consequences following abdominoplasty or laparoscopy/laparotomy gynecologic…
- Trial name
- NCT01438125
- Testing
- MF-4181, Standard surgical wound closure
- Where
- 3 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Halscion, Inc.
Incisional Hernia, Incisional Hernia of Midline of Abdomen
Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line…
- Conditions
- Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
- Trial name
- MARS (NCT05424484)
- Testing
- Self-Gripping Resorbable Mesh
- Where
- 13 sites in Croatia, Germany and 3 more
- Volunteers
- 123 people
- Sponsor
- Medtronic - MITG
Gastrointestinal Diseases, Laparotomy
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial.
- Conditions
- Gastrointestinal Diseases, Laparotomy, Anastomosis, Surgical, Absorbable, Coated Sutures
- Trial name
- NCT00645684
- Testing
- Gastrointestinal Anastomosis
- Where
- 3 sites in Hungary
- Volunteers
- 210 people
- Sponsor
- Aesculap AG
Pain, Postoperative
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy…
- Trial name
- MATRIX-1 (NCT02523599)
- Testing
- XaraColl
- Where
- 23 sites in United States
- Volunteers
- 305 people
- Sponsor
- Innocoll
Incisional Hernia After Midline Laparotomy, Colorectal Cancer
A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases.
- Trial name
- NCT07766044
- Testing
- Device assisted laparotomy closure, Manual laparotomy closure
- Where
- Sweden
- Volunteers
- 218 people
- Sponsor
- Suturion AB