Closed vs. Open Abdomen Management for Sepsis
Recruiting in Palo Alto (17 mi)
Overseen byAndrew W Kirkpatrick, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
Disqualifiers: Pregnant, Severe IAH, Pancreatitis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a prospective randomized clinical study. The study will comprise the randomized decision to either A) primarily close the fascia after laparotomy for intra-abdominal infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary abdominal closure (TAC) device (OPEN) with a vacuum drain.
Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current suggested standard of care. Thus, high quality data to direct clinical decision making in this highly lethal condition is urgently required.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Closed Abdomen Management for Sepsis?
Research suggests that using vacuum-assisted closure (VAC) for managing an open abdomen in septic patients can lead to faster abdominal closure and fewer complications compared to other methods. This implies that similar techniques in closed abdomen management might also be effective in improving outcomes for sepsis patients.
12345Is temporary abdominal closure generally safe for humans?
Temporary abdominal closure (TAC) is commonly used in cases of trauma and infection, and while it is generally safe, it can lead to complications such as the need for further abdominal wall reconstruction in some patients.
12567How does the treatment for sepsis using closed vs. open abdomen management differ from other treatments?
This treatment is unique because it compares two approaches: keeping the abdomen closed after surgery or leaving it open with a temporary closure using a special dressing. The open abdomen method allows for better management of infection and swelling, but it is controversial due to potential complications, while the closed method aims for quicker recovery by closing the abdomen sooner.
24589Eligibility Criteria
This trial is for adults with severe abdominal sepsis, indicated by specific scores like the World-Society-of-Emergency-Surgery-Sepsis-Severity Score >8. It's not for pregnant individuals, those with high intra-abdominal pressure (IAP>20 mmHg), patients without plans for continued care, cases of pancreatitis-induced peritonitis, or uncontrolled bleeding.Inclusion Criteria
I am currently experiencing septic shock.
World-Society-of-Emergency-Surgery-Sepsis-Severity-Score > 8
Predisposition-Infection-Response-Organ Dysfunction Score > 3
+1 more
Exclusion Criteria
My peritonitis is caused by pancreatitis.
I do not have any ongoing issues with uncontrolled bleeding.
I do not plan to continue receiving treatment.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo either closed or open abdomen management with ANPPT dressing after laparotomy for severe intra-abdominal infection
24-72 hours
Intra-operative randomization and initial post-operative care
Follow-up
Participants are monitored for survival, blood IL-6 levels, and ICU stay duration
90 days
Regular follow-up visits and monitoring
Post-operative Care
Formal abdominal closure or dressing change at 24-72 hours from placement
1-3 days
Participant Groups
The study compares two methods to manage abdominal infections after surgery: 'Closed Abdomen Management' where the surgical cut is closed right away and 'Open Abdomen Management' where it's left open with a vacuum dressing applied. Participants are randomly assigned to one of these treatments.
2Treatment groups
Active Control
Placebo Group
Group I: Open Abdomen Management with ANPPT dressingActive Control1 Intervention
The abdominal fascia will not be closed, but a temporally abdomenal closure (TAC) dressing (such as AbThera dressing) will be placed to protect the viscera with active Negative Pressure Peritoneal drain. Formal abdominal closure or dressing change at 24-72 hours from placement should be performed.
Group II: Closed Abdomen ManagementPlacebo Group1 Intervention
Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain). Any decision to perform a re-laparotomy will be at the discretion of the treating surgical team.
Closed Abdomen Management is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Primary Fascial Closure for:
- Abdominal sepsis
- Intra-abdominal infection
🇺🇸 Approved in United States as Primary Fascial Closure for:
- Abdominal sepsis
- Intra-abdominal infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Foothills Medical CentreCalgary, Canada
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
Alberta Health servicesCollaborator
References
The impact of standardized protocol implementation for surgical damage control and temporary abdominal closure after emergent laparotomy. [2020]To standardize care and promote early fascial closure among patients undergoing emergent laparotomy and temporary abdominal closure (TAC), we developed a protocol addressing patient selection, operative technique, resuscitation strategies, and critical care provisions. We hypothesized that primary fascial closure rates would increase following protocol implementation with no difference in complication rates.
Temporary closure of the open abdomen: a systematic review on delayed primary fascial closure in patients with an open abdomen. [2022]This study was designed to systematically review the literature to assess which temporary abdominal closure (TAC) technique is associated with the highest delayed primary fascial closure (FC) rate. In some cases of abdominal trauma or infection, edema or packing precludes fascial closure after laparotomy. This "open abdomen" must then be temporarily closed. However, the FC rate varies between techniques.
The value of vacuum-assisted closure in septic patients treated with laparostomy. [2012]The ideal method of temporary abdominal closure (TAC) should allow rapid closure, easy maintenance, and wound repair with minimal tissue damage. The aim of this retrospective study is to compare open abdomen outcomes between patients managed with vacuum-assisted closure (VAC), and patients managed with other methods of TAC, when septic abdomen is present. Two groups of patients with septic open abdomen: 27 treated with VAC versus 31 treated with other techniques of TAC. We studied open abdomen duration, number of dressing changes, re-exploration rate, successful abdominal closure rate, overall mortality, and development of enteroatmospheric fistulas. The VAC device demonstrated its superiority concerning open abdomen duration (P
Open abdomen with negative pressure device vs primary abdominal closure for the management of surgical abdominal sepsis: a retrospective review. [2017]Open abdomen with temporary abdominal closure remains a controversial management strategy for surgical abdominal sepsis compared with primary abdominal closure (PAC) and on-demand laparotomy. The primary objective was to compare mortality between PAC and open abdomen with vacuum assisted closure (VAC).
Temporary abdominal closure for trauma and intra-abdominal sepsis: Different patients, different outcomes. [2018]Temporary abdominal closure (TAC) after damage control surgery (DCS) for injured patients has been generalized to septic patients. However, direct comparisons between these populations are lacking. We hypothesized that patients with intra-abdominal sepsis would have different resuscitation requirements and lower primary fascial closure rates than trauma patients.
Managing the open abdomen in a district general hospital. [2021]The need to manage an open abdomen is becoming more common in general surgical practice and a variety of methods of temporary abdominal closure (TAC) are available. The evidence for the efficacy of the various forms of TAC as well as the subsequent definitive fascial closure (DFC) rates and complications comes mainly from large trauma series in the US, which represent a different patient population to those in the UK in whom TAC is usually required.
Outcome of open abdominal management following military trauma. [2021]Temporary abdominal closure (TAC) is increasingly common after military and civilian major trauma. Primary fascial closure cannot be achieved after TAC in 30 per cent of civilian patients; subsequent abdominal wall reconstruction carries significant morbidity. This retrospective review aimed to determine this morbidity in a UK military cohort.
Management and treatment options for patients with open abdomen. [2017]Abdominal sepsis and trauma are the main indications for open abdomen. However, there is no robust evidence that open abdomen is better than closed in these cases. When using open abdomen, treatment goals are to control the source of infection, protect the bowel from damage, minimise adhesions between the bowel and abdominal wall, facilitate nursing care and allow permanent closure of the wound by bringing the fascial edges closer. Several temporary abdominal closure techniques exist, but are associated with high mortality and morbidity rates. There is no evidence that any specific temporary abdominal closure technique is better than others; however, negative pressure wound therapy appears to be a popular method of management of open abdomen.
Fascial closure after open abdomen: initial indication and early revisions are decisive factors--a retrospective cohort study. [2022]The surgical treatment method in which the peritoneal cavity is opened anteriorly and deliberately left open, hence often called "open abdomen" has become the standard of care in damage-control procedures as well as in the management of intra-abdominal hypertension and in severe intra-abdominal sepsis. Whereas open abdomen has been closed in two stages traditionally, a modern trend is to close the fascial layers within the initial hospitalization to avoid complications like enterocutaneous fistula and hernia formation. The aim of this study was to determine crucial factors influencing the possibility of fascial closure after open abdomen.