UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020391 |
|---|---|
| Receipt number | R000023388 |
| Scientific Title | Prospective study of efficacy of Negative-pressure wound therapy (NPWT) for dirty abdominal wound after lower gastrointestinal perforation. |
| Date of disclosure of the study information | 2015/12/30 |
| Last modified on | 2020/08/04 09:42:42 |
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Basic information
Public title
Prospective study of efficacy of Negative-pressure wound therapy (NPWT) for dirty abdominal wound after lower gastrointestinal perforation.
Acronym
Prospective study of efficacy of Negative-pressure wound therapy (NPWT) for dirty abdominal wound after lower gastrointestinal perforation.
Scientific Title
Prospective study of efficacy of Negative-pressure wound therapy (NPWT) for dirty abdominal wound after lower gastrointestinal perforation.
Scientific Title:Acronym
Prospective study of efficacy of Negative-pressure wound therapy (NPWT) for dirty abdominal wound after lower gastrointestinal perforation.
Region
| Japan |
Condition
Condition
Lower gastrointestinal perforation
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Negative Pressure Wound Therapy: NPWT for post-operative surgical site infection prevention after the lower gastrointestinal perforation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of surgical site infection within 30days from wound suturing.
Key secondary outcomes
The postoperative hospital stay, the presence of reopened wound, the presence and degree of adverse events, The duration of wound healing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
For the patients with dirty abdominal wound after lower gastrointestinal perforation, primary skin closure is not perfomed. Therefore, negative pressure wound therapy is started within 3 days and continued for 5-7 days. After recognizing a formation of wound granulation, the wound is closed by suture (Delayed Primary Closure).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, The patients with dirty abdominal wound after lower gastrointestinal perforation
2, Older than 20 years old
3, Estimated survival is over 6 months
4, Documented informed consent
Key exclusion criteria
1, Naked blood vessel suspected of bleeding or surgical site infection to directly contact to other organs or the presence of fistula to abdominal cavity.
2, The presence of organ/space surgical site infection
3, The patient corresponding to the VAC treatment system Contraindications.
4, As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsuki |
| Middle name | |
| Last name | Danno |
Organization
Minoh City Hospital
Division name
Department of Gastroenterological Surgery
Zip code
562-0014
Address
7-1 Kayano5chome Minoh City Osaka 562-0014
TEL
+81-72-728-2001
k.danno@minoh-hp.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
81-6-6879-3251
Homepage URL
muemura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Osaka University, Graduate School of Medicine
Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
Tel
81-6-6879-3251
muemura@gesurg.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jarc/4/3/4_2019-043/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jarc/4/3/4_2019-043/_article/-char/ja
Number of participants that the trial has enrolled
51
Results
Five patients had surgical site infections (SSIs) during NPWT and did not receive a DPC (9%). Of the 51 patients that received DPCs, 44 had no infection (91%) and 7 developed SSIs after the DPC (13.7%). For stages II, III, and IV, the SSI rates were 0%, 22.6%, and 35.7%, respectively; the median (range) times to wound healing were 15 (10-36), 19 (11-99), and 19 (10-53) days, respectively. There were no significant differences between the stages.
Results date posted
| 2020 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 68 years (31-94), 30 males and 26 females.There were 36 (64.3%) perforation of the large intestine, 6 (10.7%) of the perforation of the small intestine, and 14 (25.0%) of the perforation of the appendix. There were 11 Hinchey classification Stage IIs, 31 IIIs, and 14 IVs.
Participant flow
Among 60 patients that underwent surgery for peritonitis secondary to a lower gastrointestinal perforation, only one was ineligible for the study due to a stage I classification. In addition, three patients underwent re-operations due to anastomotic leakage or repeated perforations. These three patients were excluded from analysis because re-operated wounds could not be evaluated. Thus, the study included 56 patients that received NPWT following surgery before attempting a DPC.
Adverse events
The incidence of treatment-related AEs was evaluated from the time of NPWT initiation. Fascial dehis- cence was observed in one case. Four patients experienced pain that did not require analgesics. However, four patients
developed SSIs, of which two were deep-layer infections.
Outcome measures
Five patients had surgical site infections (SSIs) during NPWT and did not receive a DPC (9%). Of the 51 patients that received DPCs, 44 had no infection (91%) and 7 developed SSIs after the DPC (13.7%). For stages II, III, and IV, the SSI rates were 0%, 22.6%, and 35.7%, respectively; the median (range) times to wound healing were 15 (10-36), 19 (11-99), and 19 (10-53) days, respectively. There were no significant differences between the stages.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023388
