NCT02029339

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Infection

Interventions

Type	Name	Description
DEVICE	Continuous topical triple-tube irrigation and suction	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).
DEVICE	SOC	Debridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections.

Timeline

• Start date: 2007-01-01
• Primary completion: 2013-01-01
• Completion: 2013-12-01
• First posted: 2014-01-07
• Last updated: 2014-08-01

Locations

1 site across 1 country: China