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Clinical Trials/NCT06556030
NCT06556030Not yet recruitingPhase 4

Botulinum Toxin in Open Abdomen Closure

Instituto de Investigación Hospital Universitario La Paz0 sites50 target enrollmentStarted: January 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
Main Endpoint

Study Overview

Brief Summary

A multicentre, randomised, single-blind, controlled protocol to evaluate the efficacy of early administration of botulinum toxin for primary midline closure in patients with open abdomen. Early use (less than 48 hours) of botulinum toxin as a neuromuscular abdominal wall blocker in patients whose abdomen is left open, regardless of the cause, will improve postoperative outcome and prognosis, leading to significantly higher percentages of primary midline closure.

Detailed Description

According to the definition of the World Society for Emergency Surgery (WSES), an open abdomen is defined as the intentional creation of a laparostomy by non-approximation of the aponeurotic edges of the rectus abdominis muscles in the midline (1). This technique is restricted to very specific situations, usually in the critically ill patient who has undergone damage control surgery for polytrauma, abdominal sepsis or abdominal compartment syndrome. In this context, it may be necessary to keep the abdomen open for four indications that were defined in 2015 by an international consensus of experts:

need for reintervention (second-look) in cases of ischaemia or severe intra-abdominal contamination; inability to close due to visceral oedema; traumatic damage to the abdominal wall; failure of medical treatment in the management of abdominal compartment syndrome (2).

Since its description in 1993 (although open abdomen was used for abdominal compartment syndrome decades earlier), the use of damage control surgery associated with intensive resuscitation has decreased mortality in these patients from 90% to approximately 20-30% today (3).

Despite its benefits for the survival of unstable patients, the creation of an open abdomen creates a non-anatomical situation with significant physiological repercussions: exposure of the abdominal viscera to the environment without barrier mechanisms results in hypothermia, and significant fluid and protein loss, precipitating a catabolic state that feeds back into the multi-organ failure of the critically ill patient. In addition, the open abdomen leads to potentially very serious complications such as the development of an enteroatmospheric fistula, which occurs in up to 15% of these patients (2,4,5).

In order to reduce complications and simplify the management of patients with open abdomen, various temporary closure devices have been developed (5). Among them, current evidence recommends the use of negative pressure devices, generally consisting of: a sheet of non-absorbable plastic material in contact with the viscera that tries to prevent the appearance of adhesions and fistulas and which, by presenting small perforations, allows intra-abdominal fluid to escape, a macroporous material that remains in lateral contact with the fascia and subcutaneous tissue, and a final occlusive cover to which suction is applied to generate the negative pressure. The incorporation of these devices has been shown to reduce the production of proinflammatory cytokines in the peritoneal fluid (6) and the aforementioned guidelines recommend their use in all cases of open abdomen (grade of recommendation B, level of evidence I)(2).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects must be able to understand the purpose and risks of the study, giving informed consent and authorising the use of confidential health information. If the patient is unable to consent due to emergency status, a first or second degree relative will be requested. If the patient recovers, the patient's consent to continue participation will be sought again.
  • Subjects Patients over 18 years of age who, regardless of the cause, have undergone abdominal surgery, after which it has been necessary to leave the abdomen open.
  • Subjects able and willing to participate and to be followed for most of the duration of the study.

Exclusion Criteria

  • Personal historyDiseases which, in the opinion of the investigator, may interfere with or worsen the action of the botulinum toxin. For example, patients with: hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton Lamber syndrome or ALS are excluded.
  • Drugs that affect muscle tone or the autonomic nervous system, e.g. administration of antibiotics such as aminoglycosides, lincosamides, polymyxins or tetracyclines.
  • Pregnancy or lactation.
  • Known hypersensitivity.
  • Active neoplastic disease.

Arms & Interventions

Control

Placebo Comparator

physiological saline 50 cc

Intervention: CONTROL (Other)

botulinum toxin

Experimental

Intramuscular injection into the flat muscles of the abdominal wall of 300/500 Units of botulinum toxin A dissolved in 100 cc of physiological saline, distributed in 5 points on each side of the abdomen in the first 48 hours after leaving the abdomen open.

Intervention: Botulinum Toxin A (Drug)

Outcomes

Primary Outcomes

Main Endpoint

Time Frame: 30 days

Percentage of patients achieving primary midline closure in the experimental group compared to the control group (within 20 days after the first procedure where the abdomen is left open).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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