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

Primary Purpose

Wound Infection

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Continuous topical triple-tube irrigation and suction

SOC

About this trial

This is an interventional treatment trial for Wound Infection focused on measuring Negative pressure wound therapy, Acute wound infection, complicated abdominal infection, Cytokines, Matrix metalloproteinase

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Surgery, Zhongda Hospital, Southeast University Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

triple-tube group

SOC group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Delayed primary fascial closure

Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02029339

First Posted

December 28, 2013

Last Updated

July 31, 2014

Sponsor

Southeast University, China

1. Study Identification

Unique Protocol Identification Number

NCT02029339

Brief Title

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

Acronym

Triple-tube

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southeast University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

triple-tube group

Arm Type

Experimental

Arm Description

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

Arm Title

SOC group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Continuous topical triple-tube irrigation and suction

Intervention Description

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

Intervention Name(s)

SOC

Other Intervention Name(s)

standard of care

Intervention Description

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

Primary Outcome Measure Information:

Title

Delayed primary fascial closure

Description

Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay

Time Frame

Up to 8 weeks

Secondary Outcome Measure Information:

Title

Levels of cytokines/proteinase in wound fluid

Description

Time Frame

Up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qingsong Tao, MD, PhD

Organizational Affiliation

Department of Surgery, Zhongda Hospital, Southeast University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Surgery, Zhongda Hospital, Southeast University Medical School

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210089

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

18593390

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.

Results Reference

background

PubMed Identifier

17000077

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.

Results Reference

background

PubMed Identifier

24049811

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.

Results Reference

background

PubMed Identifier

24106564

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.

Results Reference

background

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

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