UMIN-CTR Clinical Trial

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

Lower gastrointestinal perforation

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

k.danno@minoh-hp.jp

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

Email

muemura@gesurg.med.osaka-u.ac.jp

Institute

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Institute

Department

Personal name

Organization

Osaka University, Graduate School of Medicine
Department of Gastroenterological Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

muemura@gesurg.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

30

Day

URL releasing protocol

https://www.jstage.jst.go.jp/article/jarc/4/3/4_2019-043/_article/-char/ja

Publication of results

Published

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

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 related 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