Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Peritoneal Vacuum Therapy to Reduce the Systemic Inflammatory Insult From Intraperitoneal Sepsis/Injury/Hypertension: A Randomized Comparison of Baseline Wall Suction Versus the KCI AbThera™ Abdominal Dressing
Brief Summary: This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid through the use of a commercial suction device compared to passive drainage of the same peritoneal fluid drained through standard surgical drains under bulb suction only, in critically ill patients who require an "open abdomen". Both techniques being used, the commercial KCI AbThera™ device and home made "Stampede" VAC system, are currently approved for use in Canada and used in our facility.

The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal closure (TAC) techniques, resulting in an "open abdomen"(OA). The decision to accept an OA can only be made in the operating room and is typically made quite arbitrarily (there is no current standard or protocol),and the TAC used is based on the surgeon's best judgment. The study intends to randomize patients after it has been decided that a TAC is required, which will be applied in the operating room while the patient is fully anesthetized. The only intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal fluid-that is typically discarded in patients with OA.


Options:
A: Arm Label: Open Abdomen - Vacuum Pack; Type: EXPERIMENTAL; Interventions: Device: Vacuum Pack | Arm Label: Double Sylo Bag - Mesh Protocol; Type: ACTIVE_COMPARATOR; Interventions: Device: Double Sylo Bag - Mesh Protocol | Intervention Type: DEVICE; Name: Vacuum Pack; Assigned to Arm(s): Open Abdomen - Vacuum Pack | Intervention Type: DEVICE; Name: Double Sylo Bag - Mesh Protocol; Assigned to Arm(s): Double Sylo Bag - Mesh Protocol
B: Arm Label: Open Abdomen Management with ANPPT dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Open Abdomen Management with ANPPT dressing | Arm Label: Closed Abdomen Management; Type: SHAM_COMPARATOR; Interventions: Other: Closed Abdomen Management | Intervention Type: DEVICE; Name: Open Abdomen Management with ANPPT dressing; Assigned to Arm(s): Open Abdomen Management with ANPPT dressing | Intervention Type: OTHER; Name: Closed Abdomen Management; Assigned to Arm(s): Closed Abdomen Management
C: Arm Label: Open Abdomen patients; Type: N/A; Interventions: Procedure: Open abdomen procedure | Intervention Type: PROCEDURE; Name: Open abdomen procedure; Assigned to Arm(s): Open Abdomen patients
D: Arm Label: "Stampede" VAC; Type: ACTIVE_COMPARATOR; Interventions: Device: "Stampede" VAC | Arm Label: KCI AbThera; Type: EXPERIMENTAL; Interventions: Device: KCI AbThera | Intervention Type: DEVICE; Name: KCI AbThera; Assigned to Arm(s): KCI AbThera | Intervention Type: DEVICE; Name: "Stampede" VAC; Assigned to Arm(s): "Stampede" VAC

Answer: D