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

NCT02029339 | Completed DMC

• 1 other identifier: 81000153
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection

Keywords

Negative pressure wound therapy; Acute wound infection; complicated abdominal infection; Cytokines; Matrix metalloproteinase

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Levels of cytokines/proteinase in wound fluid

  Up to 8 weeks

Study Arms (2)

triple-tube group

EXPERIMENTAL

The patients were treated with continuous topical triple-tube irrigation and suction

Device: Continuous topical triple-tube irrigation and suction

SOC group

ACTIVE COMPARATOR

The patients were treated with standard of care (SOC) without topical irrigation

Device: SOC

Interventions

Continuous topical triple-tube irrigation and suction DEVICE

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).

triple-tube group

SOC DEVICE

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

Also known as: standard of care

SOC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Department of Surgery, Zhongda Hospital, Southeast University Medical School

Nanjing, Jiangsu, 210089, China

Location

Related Publications (4)

• 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.

  PMID: 18593390 BACKGROUND

• 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.

  PMID: 17000077 BACKGROUND

• 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.

  PMID: 24049811 BACKGROUND

• 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.

  PMID: 24106564 BACKGROUND

MeSH Terms

Conditions

Wound Infection

Interventions

Suction

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Qingsong Tao, MD, PhD

  Department of Surgery, Zhongda Hospital, Southeast University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Surgeon

Study Record Dates

• First Submitted: December 28, 2013
• First Posted: January 7, 2014
• Study Start: January 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 1, 2014

Record last verified: 2014-01

Locations

CN (1)