Clinical trial NCT02029339: Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
Official title: Continuous Topical Triple-tube Instillation and Suction for for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Keywords: Negative pressure wound therapy
Acute wound infection
complicated abdominal infection
Cytokines
Matrix metalloproteinase
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delayed primary fascial closure
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Levels of cytokines/proteinase in wound fluid
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Surgery, Zhongda Hospital, Southeast University Medical School
state: Jiangsu
Study officials:
affiliation: Department of Surgery, Zhongda Hospital, Southeast University Medical School
name: Qingsong Tao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/j.jvs.2006.07.030. Epub 2006 Sep 26.
citation: Fluieraru S, Bekara F, Naud M, Herlin C, Faure C, Trial C, Teot 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. doi: 10.12968/jowc.2013.22.6.293.
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.