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

Wound Infection Clinical Trial

— Triple-tube  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029339
• Other study ID #: 81000153
• Status: Completed
• Phase: N/A
• First received: December 28, 2013
• Last updated: July 31, 2014
• Start date: January 2007
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intraabdominal Infections
• Wound Infection

Intervention

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

Locations

Country	Name	City	State
China	Department of Surgery, Zhongda Hospital, Southeast University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

References & Publications (4)

Fluieraru S, Bekara F, Naud M, Herlin C, Faure C, Trial C, Téot L. Sterile-water negative pressure instillation therapy for complex wounds and NPWT failures. J Wound Care. 2013 Jun;22(6):293-4, 296, 298-9. — View Citation

Gabriel A, Shores J, Heinrich C, Baqai W, Kalina S, Sogioka N, Gupta S. Negative pressure wound therapy with instillation: a pilot study describing a new method for treating infected wounds. Int Wound J. 2008 Jun;5(3):399-413. doi: 10.1111/j.1742-481X.2007.00423.x. — View Citation

Lessing MC, James RB, Ingram SC. Comparison of the Effects of Different Negative Pressure Wound Therapy Modes-Continuous, Noncontinuous, and With Instillation-on Porcine Excisional Wounds. Eplasty. 2013 Oct 1;13:e51. eCollection 2013. — View Citation

Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC. State-of-the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg. 2006 Nov;44(5):1029-37; discussion 1038. Epub 2006 Sep 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed primary fascial closure	Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay	Up to 8 weeks	No
Secondary	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.	Up to 8 weeks	No