Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections (Triple-tube)

Southeast University, China

Status: Completed

Conditions: Wound Infection

Treatments: Device: Continuous topical triple-tube irrigation and suction; Device: SOC

Study type: Interventional

Funder types: Other

Identifiers

NCT02029339

81000153

Details and patient eligibility

About

The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually avoided in infected or critical colonized wounds. To our observation, the additional continuous irrigation tube attached beside the suction tube in the NPWT system could provide the effective drainage by reducing the occlusion of suction tube, enable effective debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by providing relatively moist ambient. At our institutions, the modified system combined with a "triple-tube" device to allow a continuous instillation became more active and efficient. The study is to investigate if a continuous triple-tube instillation and suction could improve the outcomes of acute severely infected open abdomen.

Full description

This study was performed on the patients with a severely complicated infected open abdomen treated with topical triple-tube irrigation and suction, compared with a control group of the patients treated with standard NPWT without topical irrigation. The clinical outcomes were recorded. Profiles of cytokines/proteinase in wound fluid were quantified weekly.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM)
• Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf.
• Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck.

Exclusion criteria

• < 18 years,
• pre-existing large ventral hernia
• Frozen OA with adherent bowel (OA of grade 4),
• Clean wound (OA of grade 1a or 2a)
• chronic wound infection
• critical wound ischemia
• severe systemic infection
• end-stage renal disease
• severe liver disease
• uncontrolled diabetes mellitus
• any issue with an obviously high risk of delayed wound healing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

triple-tube group

Experimental group

Description:

The patients were treated with continuous topical triple-tube irrigation and suction

Treatment:

Device: Continuous topical triple-tube irrigation and suction

SOC group

Active Comparator group

Description:

The patients were treated with standard of care (SOC) without topical irrigation

Treatment:

Device: SOC