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

N/ACompletedNCT02029339

Southeast University, China32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wound Infection

Interventions

Continuous topical triple-tube irrigation and suctionDEVICE

The triple-tube device was continuous operated: instilled the topical solution through the "washing tube", delivered negative pressure therapy at 100 - 125 mmHg continuously through the inner tube of "sleeve tubes" through the central negative pressure device in the wall of the ward. The outer tube was used for normalize and balance the distribution of the negative pressure around the inner tube to allow the solution to penetrate through the dressing to cover the wound, and protecting the inner tube from getting stuck with the sucked tissue. All tubes are all commercially available (Medical Silicone Tubing, Forbest Manufacturing Co., Ltd, China).

SOCDEVICE

Debridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Delayed primary fascial closure

Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay

Time frame: Up to 8 weeks

Secondary Outcomes

Levels of cytokines/proteinase in wound fluid

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.