Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000149268
Ethics application status
Approved
Date submitted
23/01/2009
Date registered
16/03/2009
Date last updated
16/03/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized Contolled Trial of Managing Infected Abdominal Wound by Continuous Irrigation and Negative Pressure Suction versus Open Wound Dressings followed by Secondary Suturing
Scientific title
A Randomized Contolled Trial of Managing Infected Abdominal Wound by Continuous Irrigation and Negative Pressure Suction versus Open Wound Dressings followed by Secondary Suturing in Patients with Abdominal Surgical Wound Infection.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To investigate the effect of method of continue clysis and negative pressure drainage using tube in the treatment of the abdominal surgical wound infection 4227 0
Condition category
Condition code
Surgery 4447 4447 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TO treatment infected abdominal wound using 500ml normal saline twice daily for 7 days to continuous irrigation and negative pressure suction by the subcutaneous tube
Intervention code [1] 4223 0
Treatment: Surgery
Comparator / control treatment
TO treatment infected abdominal wound apply the method of traditional incisional change dressings daily for 5 to 7 days and followed by second suture
Control group
Active

Outcomes
Primary outcome [1] 5529 0
time of wound healing monitored by health care professinals
Timepoint [1] 5529 0
moniotored on a daily from baseline to day 20.
Secondary outcome [1] 9311 0
Hospital stay after surgery
Timepoint [1] 9311 0
moniotored on a daily from baseline to day 20

Eligibility
Key inclusion criteria
a. wound infection with pustular discharge on postoperative day 3 to day 7
b. confirmed wound infection with positive microorganism growth in the pus culture
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. wound infection associated with enteric pancreatic or biliary fistula;
b. patients with intra-abdominal abscess;
c. patients who has diabetes mellitus or immunosuppression;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1545 0
China
State/province [1] 1545 0

Funding & Sponsors
Funding source category [1] 4625 0
Self funded/Unfunded
Name [1] 4625 0
Zuojun Zhen
Country [1] 4625 0
China
Primary sponsor type
Individual
Name
Zuojun Zhen
Address
Department of Hepatobiliary Surgery ,the First People’s Hospital of Foshan,N0.81,Ling-Nan Road,Foshan City,Guangdong Province,China
Country
China
Secondary sponsor category [1] 4169 0
None
Name [1] 4169 0
Address [1] 4169 0
Country [1] 4169 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
method of continue irrigation and negative pressure drainage using tube in the treatment of the abdominal surgical wound infection is feasible and accelerate the cure of incision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29212 0
Address 29212 0
Country 29212 0
Phone 29212 0
Fax 29212 0
Email 29212 0
Contact person for public queries
Name 12459 0
Fengjie Wang
Address 12459 0
Department of Hepatobiliary Surgery ,the First People’s Hospital of Foshan,N0.81,Ling-Nan Road,Foshan City,Guangdong Province,China
Country 12459 0
China
Phone 12459 0
0757-83161116
Fax 12459 0
Email 12459 0
[email protected]
Contact person for scientific queries
Name 3387 0
Qinghan Li
Address 3387 0
Department of Hepatobiliary Surgery ,the First People’s Hospital of Foshan,N0.81,Ling-Nan Road,Foshan City,Guangdong Province,China
Country 3387 0
China
Phone 3387 0
0757-83161119
Fax 3387 0
Email 3387 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.