UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043081 |
|---|---|
| Receipt number | R000049180 |
| Scientific Title | Surgical site infection following abdominal surgery: A randomized control trial comparing common dressing and antimicorobial dressing containing ionic silver (Aquacel Ag Hydrofiber) |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2026/07/27 09:47:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Surgical site infection following abdominal surgery: A randomized control trial comparing common dressing and antimicorobial dressing containing ionic silver (Aquacel Ag Hydrofiber)
Acronym
Surgical site infection following abdominal surgery: A randomized control trial comparing common dressing and antimicorobial dressing containing ionic silver (Aquacel Ag Hydrofiber)
Scientific Title
Surgical site infection following abdominal surgery: A randomized control trial comparing common dressing and antimicorobial dressing containing ionic silver (Aquacel Ag Hydrofiber)
Scientific Title:Acronym
Surgical site infection following abdominal surgery: A randomized control trial comparing common dressing and antimicorobial dressing containing ionic silver (Aquacel Ag Hydrofiber)
Region
| Japan |
Condition
Condition
Patients undergoing abdominal digestive surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the efficacy and safety of Aquacel Ag Hydrofiber dressing in preventing superficial surgical site infection (SSI).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of superficial SSI comparing between Aquacel Ag Hydrofiber dressing group and topical agent group within 30 days after digestive surgery.
Key secondary outcomes
The comparison of the incidence of superficial SSI in the patient's characteristics of clinical and surgical features.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After the skin closure, Aquacel Ag hydrofiber, width of 1.0-1.5 cm in diameter, is placed over the incision and covered with a film dressing to the patients assigned to Ag group.
After 48 hours from surgery, Aquacel dressing and film are removed.
Interventions/Control_2
After the skin closure, control group are used a film dressing as standard wound dressing.
After 48 hours from surgery, film dressing is removed.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) elective or emergent digestive surgery.
2)age 15 years or older.
3)Patients undergoing laparoscopic surgery or open surgery.
4)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Key exclusion criteria
patients with the following levels of bone marrow, hepatic, and renal function based on the data obtained within 1 week before enrollment.
1)white blood cell count <4,000/mm3 and >12,000mm3
2)platelet count <100,000mm3
3)hemoglobin <9.0 g/dL
4)total bilirubin >2.0 mg/dL, asparate aminotransferase (AST) / glutamate oxaloacetate transaminase (GOT) > 100 IU/L, alanine aminotransferase (AST) / glutamate pyruvate transaminase (GPT) >100 IU/L
5)serum creatinine below the institutional upper limit of normal
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Koda |
Organization
Teikyo University Chiba Medical Center
Division name
Department of Surgery
Zip code
299-0111
Address
3426-3 Anesaki, Ichihara, Chiba, Japan
TEL
0436-62-1211
k-koda@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Kosugi |
Organization
Teikyo University Chiba Medical Center
Division name
Department of Surgery
Zip code
299-0111
Address
3426-3 Anesaki, Ichihara, Chiba, Japan
TEL
0436-62-1211
Homepage URL
ckosugi0126@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery, Teikyo University Chiba Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel
03-3964-7256
turb-office@teikyo-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
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ovid.com/jnls/aosopen/fulltext/10.1097/as9.0000000000000402~a-randomized-trial-of-ionic-
Publication of results
Partially published
Result
URL related to results and publications
https://www.ovid.com/jnls/aosopen/fulltext/10.1097/as9.0000000000000402~a-randomized-trial-of-ionic-
Number of participants that the trial has enrolled
800
Results
The overall rate of superficial SSIs was significantly lower in the study group than in the control group. There was no significant difference in superficial SSI rates between the groups in patients undergoing upper gastrointestinal surgery; however, the rate was significantly lower in the study group in patients undergoing lower gastrointestinal surgery. Multivariate analysis identified Aquacel Ag Hydrofiber dressings as an independent factor for reducing superficial SSIs.
Results date posted
| 2026 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To determine whether Aquacel Ag Hydrofiber dressings containing ionic silver are superior to film dressings for preventing superficial surgical site infections (SSI) in patients undergoing elective gastrointestinal surgery. Multiple clinical trials have assessed the effectiveness of silver-containing wound dressings; however, systematic reviews failed to find any advantages of these dressings and concluded that there was insufficient evidence to indicate that they prevented wound infections. This study aimed to evaluate the efficacy of Aquacel Ag Hydrofiber dressings for preventing superficial SSIs in patients undergoing gastrointestinal surgery.
Participant flow
Patients undergoing elective gastrointestinal surgery were randomly assigned to receive either Aquacel Ag Hydrofiber (study group) or film dressings (control group). The primary end point was superficial SSI within 30 days after surgery.
Adverse events
There were no adverse events, such as allergic reactions or wound pain, that could be attributed to Aquacel Ag Hydrofiber.
Outcome measures
A total of 865 patients (427 study group, 438 control group) were qualified for primary end-point analysis. The overall rate of superficial SSIs was significantly lower in the study group than in the control group (6.8% vs 11.4%, P = 0.019). There was no significant difference in superficial SSI rates between the groups in patients undergoing upper gastrointestinal surgery; however, the rate was significantly lower in the study group in patients undergoing lower gastrointestinal surgery (P = 0.042). Multivariate analysis identified Aquacel Ag Hydrofiber dressings as an independent factor for reducing superficial SSIs (odds ratio, 0.602; 95% confidence interval, 0.367-0.986; P = 0.044).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049180
