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

Not Applicable

Completed

• Conditions: Wound Infection
• Interventions: Device: Continuous topical triple-tube irrigation and suction; Device: SOC

• Registration Number: NCT02029339
• Lead Sponsor: Southeast University, China

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2013-01
• Study Completion: 2013-12
• Study First Submitted: 2013-12-28
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-05
• Study First Posted: 2014-01-07
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
triple-tube group	Continuous topical triple-tube irrigation and suction	The patients were treated with continuous topical triple-tube irrigation and suction
SOC group	SOC	The patients were treated with standard of care (SOC) without topical irrigation

Primary Outcome Measures

Name	Time	Method
Delayed primary fascial closure	Up to 8 weeks	Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay

Secondary Outcome Measures

Name	Time	Method
Levels of cytokines/proteinase in wound fluid	Up to 8 weeks	Wound fluid was collected at the initial admission and every three days later. Before samples were collected, irrigation was released and held for 6 hours to avoid contamination or dilution by the washed solution. Wound fluid was collected using a filter paper (PerioPaper, Oraflow Inc., NY) for 30 seconds as prior described and stored at -80°C until analyses.

Trial Locations

Locations (1)

Department of Surgery, Zhongda Hospital, Southeast University Medical School; 🇨🇳 Nanjing, Jiangsu, China