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

NCT ID: NCT02029339

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

triple-tube group

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

Group Type: EXPERIMENTAL

Continuous topical triple-tube irrigation and suction

Intervention Type: 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).

SOC group

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

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

standard of care

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Qingsong Tao

Attending Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingsong Tao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Zhongda Hospital, Southeast University Medical School

Locations

Department of Surgery, Zhongda Hospital, Southeast University Medical School

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 18593390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17000077 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24049811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24106564 (View on PubMed)

Other Identifiers

81000153

Identifier Type: -

Identifier Source: org_study_id