Wound InfectionTriple-tubeNCT02029339
Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
A study testing Continuous topical triple-tube irrigation and suction and SOC in people with Wound Infection, run by Southeast University, China at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- Continuous topical triple-tube irrigation and suction and SOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- < 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
Show all 11Show fewer
- severe systemic infection
- end-stage renal disease
- severe liver disease
- uncontrolled diabetes mellitus
- any issue with an obviously high risk of delayed wound healing
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Surgery, Zhongda Hospital, Southeast University Medical School
Nanjing, Jiangsu, 210089
About this study
Official title: Continuous Topical Triple-tube Instillation and Suction for for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
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.
Read the 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
- Being tested
- Continuous topical triple-tube irrigation and suction, SOC
- Keywords
- Negative pressure wound therapy, Acute wound infection, complicated abdominal infection, Cytokines, Matrix metalloproteinase
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous topical triple-tube irrigation and suctionDevice
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).
SOCDevice
Also called standard of care
Debridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections.
| Study group | Role | What they receive |
|---|---|---|
| triple-tube group | Experimental | The patients were treated with continuous topical triple-tube irrigation and suction Receives: Device: Continuous topical triple-tube irrigation and suction |
| SOC group | Active comparator | The patients were treated with standard of care (SOC) without topical irrigation Receives: Device: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed primary fascial closure
Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay
Measured: Up to 8 weeks
Secondary outcomes (1)
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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2007
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingsong Tao, Southeast University, China
- Investigators
- Qingsong Tao, MD, PhD, Principal investigator, Department of Surgery, Zhongda Hospital, Southeast University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029339
- Sponsor's protocol ID
- 81000153
- Acronym
- Triple-tube
- Status last verified
- Jan 2014
- First submitted
- 28 Dec 2013
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18593390Vuerstaek 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.
PubMed 17000077Fluieraru 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.
PubMed 24049811Lessing 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.
PubMed 24106564
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Topical Triple-tube Instillation and Suction for for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
- ClinicalTrials.gov ID
- NCT02029339
- Acronym / sponsor ID
- Triple-tube / 81000153
- Conditions
- Wound Infection
- Keywords
- Negative pressure wound therapy, Acute wound infection, complicated abdominal infection, Cytokines, Matrix metalloproteinase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple-tube group | Experimental | Device: Continuous topical triple-tube irrigation and suctionThe patients were treated with continuous topical triple-tube irrigation and suction |
| SOC group | Active comparator | Device: SOCThe patients were treated with standard of care (SOC) without topical irrigation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous topical triple-tube irrigation and suctionThe 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). | Device | triple-tube group |
| SOCAlso: standard of careDebridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections. | Device | SOC group |
Primary outcome
Delayed primary fascial closure
Time frame: Up to 8 weeks
Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay
1 secondary outcome
Levels of cytokines/proteinase in wound fluid
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Background: PubMed 18593390Gabriel 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.
- Background: PubMed 17000077Vuerstaek 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.
- Background: PubMed 24049811Fluieraru 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.
- Background: PubMed 24106564Lessing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingsong Tao, MD, PhD principal investigator
Department of Surgery, Zhongda Hospital, Southeast University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous topical triple-tube irrigation and suction and SOC in people with Wound Infection, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed primary fascial closure (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029339, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.