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Open Abdomen clinical trials

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NCT ID: NCT06428370 Recruiting - Open Abdomen Clinical Trials

Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)

DACOSAD
Start date: January 1, 2020
Phase:
Study type: Observational

To analyze the possible benefit of damage control surgery by performing bowel resection, open abdomen, and delayed anastomosis in the treatment of Hinchey III or IV diverticulitis.

NCT ID: NCT06242925 Recruiting - Open Abdomen Clinical Trials

Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)

AbCLO
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this multicenter, prospective Cohort Interventional study is to perform a pilot study of the AbCLO (Abdominal Wall Closure) device in patients with Open Abdomen. The main question it aims to answer is: • Does the Abdominal Wall Closure Device (AbCLO) increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls? Participants will be cases of open abdomen who underwent emergency surgery for Trauma or Acute Care Surgery, will have the AbCLO device. These will be compared to historical controls managed at the same center.

NCT ID: NCT05568238 Not yet recruiting - Incisional Hernia Clinical Trials

Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen

VAWCPOM
Start date: October 2022
Phase: N/A
Study type: Interventional

Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed. Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates. Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique. Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.

NCT ID: NCT04283916 Recruiting - Open Abdomen Clinical Trials

Botulinum Toxin Injection in the Treatment of Open Abdomen

Start date: February 21, 2020
Phase:
Study type: Observational [Patient Registry]

Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.

NCT ID: NCT01968811 Completed - Open Abdomen Clinical Trials

Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen

Start date: November 2013
Phase: N/A
Study type: Interventional

The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.

NCT ID: NCT01864590 Completed - Open Abdomen Clinical Trials

Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

Start date: June 2011
Phase: N/A
Study type: Interventional

The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.

NCT ID: NCT01594385 Completed - Trauma Clinical Trials

Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients

OASIT
Start date: April 2010
Phase: N/A
Study type: Interventional

The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on: - the number and intensity of adhesions, - whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure, - rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and - whether there is any difference between treatment groups regarding patient functional recovery.

NCT ID: NCT01016353 Completed - Open Abdomen Clinical Trials

Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique

Start date: December 2009
Phase:
Study type: Observational

This study is being done to gather data that will be used to compare two different TAC (Temporary Abdominal Closure) methods that your doctor may use. The two TAC methods being compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The ABThera dressing is available commercially. Neither method will be supplied to the doctor (Principal Investigator), so that in no way would the subject's standard of care be different from what they would get if the study was not being done. This study is observational and only collects data about how the subject progresses after surgery TAC is used. When a study is observational it means that the subject's standard medical care will not be altered in any way, simply watched. The doctor will not change treatment of your open abdomen.

NCT ID: NCT01010464 Withdrawn - Open Abdomen Clinical Trials

An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen

Start date: January 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

NCT ID: NCT00834314 Terminated - Open Abdomen Clinical Trials

Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment

ABDOVAC
Start date: February 2010
Phase: N/A
Study type: Interventional

The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen. Secondary purpose is the comparison of feasibility and economic aspects.