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Surgical Site InfectionNCT03380169

Preventing Surgical Site Infection by Using Prophylactic Occlusive Ionic Silver-containing Dressing

A study testing Prophylactic advance wound dressing and Prophylactic conventional wound dressing in people with Surgical Site Infection, run by Princess Margaret Hospital, Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Ionic silver-containing dressing has been proven as a broad spectrum antimicrobial agent to reduce inflammation of wounds and promote healing. However, surgical incisions are usually dressed with conventional gauze dressing in colorectal surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infection
What is being tested?
Prophylactic advance wound dressing and Prophylactic conventional wound dressing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteHong Kong
Study dates
15 Oct 2017to Jun 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient aged 18 years or above undergo abdominal colorectal operation

Who cannot join

  • Patients with cognitive impairment
  • Patient with known allergic reactions to silver, hydrofibre or hydrocolloid
  • Patient with non-closed wound immediate after operation

Trial locations and contacts

1 site in 1 country.

Chi Yeung Cheung, BSc contact

+85261780111

ccy542@ha.org.hk

Hong Kong1 site, 1 recruiting
  • Princess Margaret Hospital

    Hong Kong

    Chi Yeung Cheung, 29901111, ccy542@ha.org.hk

    Chi Yeung Cheung

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effectiveness in Preventing Surgical Site Infection by Using Prophylactic Occlusive Ionic Silver-containing Dressing in Abdominal Colorectal Surgery Patients - Randomized Controlled Trial

Background: Ionic silver-containing dressing has been proven as a broad spectrum antimicrobial agent to reduce inflammation of wounds and promote healing. However, surgical incisions are usually dressed with conventional gauze dressing in colorectal surgery.

Objective: To compare the effectiveness in preventing surgical site infection (SSI) by using conventional gauze dressing and occlusive ionic silver-containing dressing.

Methods: This is a single-blind two-arm parallel randomized controlled trial on occlusive ionic silver-containing dressing conducted in Surgery Department of Princess Margaret Hospital. Two hundred patients who undergo emergency or elective abdominal colorectal surgery will be recruited and randomly assigned to have the surgical incisional wound dressed with conventional gauze dressing or occlusive ionic silver-containing dressing. Subjects will be assessed for SSI on day 3, 15 and 30 after operation in a clinical visit followed by phone interviews.

Read the detailed description

Background Surgical site infections According to a Clean Care is safer programme by World Health Organization(WHO), the second most frequent and surveyed health care-associated infections in high-income countries is surgical site infections (SSI). The highest SSI is the colorectal surgery with 9.5% interlude per operations. SSI develop negative influence on patient outcome, such as burden the morbidity, mortality and extra expenses to health care system. The length of stay increased 9.7 days due to SSI in 2005 in USA, and more expenses spend on the antibiotics and the advanced dressing materials. Patient suffered from SSI will double the mortality rate in USA with increased cost and readmission for the treatment.

Modern dressing There are many different treatment and dressing options for health care providers for wound care. The dressings with advanced technology become more popular in recent days. Many studies show the importance of moist wound dressing to enhance the wound healing process. It can provide a moist wound environment, absorb the excess exudate, move away the microorganism and prevent their replication, and provide a barrier from the external environment than the conventional gauze dressing. Besides, a recommendation from the UK's National Institution for Health and Clinical Excellence (NICE) suggest that all surgical incision wound should be dressed with low-adhesive dressing for at least 3-5 days after operation. And a journal published in CINAHL Information System stated that the use of dressing with moist wound healing effects can help to reduce the SSI rate by 50% that the conventional gauze. On the other hand, there are studies commended that there are no significant different in prevention of SSI with the use of moist wound dressing. Therefore, it is a controversial issue on the effectiveness of preventing SSI by using moist wound dressing versus conventional gauze dressing.

Ionic silver-containing dressing Ionic silver (Ag+), is an active state silver oxidized biologically, is proved as a broad spectrum antimicrobial agent that is effective against aerobic, anaerobic, Gram-negative and Gram-positive bacteria, as well as fungi, viruses, and yeast with minimal development of bacterial resistance. Silver is used commonly in many dressings for the antimicrobial effect. Silver containing dressing can reduce the inflammation of wounds and promotes healing, since silver cations in the dressing can destroy microorganism by inactivating bacterial enzymes, disrupting the functions of cell membrane and binding the bacterial DNA/RNA to cause cell death and inhibiting cell replication.

Abdominal Colorectal surgery and ionic silver-containing dressing in Hong Kong In Hong Kong, colorectal cancer is the commonest cancer, there were around 5000 new cases in 2014. And it is the second leading cause of cancer deaths, in 2015, around colorectal cancer caused 2000 deaths. An unpublished internal audit carried out in surgical department in Princess Margaret Hospital (PMH) in 2015 found that the day 30 post-operation SSI incidence among patients with colorectal surgery using occlusive ionic silver-containing dressing (20%; 19/95) was statistically lower than those using conventional gauze dressing (52.9%; 9/17) with p=0.012 (Table 1). Although the effect of using silver dressing to reduce SSI rate is controversial, there are no formal study has been published locally. Therefore, it is meaningful to carry out a randomized controlled trial (RCT) to prove the significance of silver dressing in reduce SSI rate.

Objective To compare the SSI incidence among patients with abdominal colorectal surgery patients using prophylactic occlusive ionic silver-containing dressing and conventional gauze dressing.

Being tested
Prophylactic advance wound dressing, Prophylactic conventional wound dressing
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic advance wound dressingOther

    A combination of dressing including occlusive moist wound dressing to provide a barrier from the external environment and silver-containing dressing to reduce the inflammation of wounds and promotes healing

  • Prophylactic conventional wound dressingOther

    Conventional gauze dressing

Study groups in NCT03380169
Study groupRoleWhat they receive
Advance dressingExperimentalProphylactic advance wound dressing
Receives: Other: Prophylactic advance wound dressing
Conventional gauze dressingActive comparatorProphylactic conventional wound dressing
Receives: Other: Prophylactic conventional wound dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess if there are any surgical site infection on post-op day 30.

    Patient's case doctor will be responsible to document in date collection form, if there are surgical site infection occur. A research team is responsible for the data collection. The definition of surgical site infection will be according to CDC definitions of nosocomial surgical site infections: a modification of CDC definitions of surgical wound infection.

    Measured: Post-op day 30

Secondary outcomes (1)
  1. To assess if there are any surgical site infection on Post-op day 3 & 15.

    Patient's case doctor will be responsible to document in date collection form, if there are surgical site infection occur. A research team is responsible for the data collection. The definition of surgical site infection will be according to CDC definitions of nosocomial surgical site infections: a modification of CDC definitions of surgical wound infection.

    Measured: Post-op day 3 & 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2017
  2. Study start15 Oct 2017
  3. Primary completionJan 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-blind two-arm parallel randomized controlled trial on occlusive ionic silver-containing dressing conducted in Princess Margaret Hospital (PMH). PMH is a major acute general hospital in Kowloon West Cluster in Hong Kong, providing 1,542 beds to maintain a wide range of specialist care. There are around 150 abdominal colorectal surgery provided every year in our department. Both the subjects, data collectors and outcome assessors will be blinded to the type of dressing being used. Eligible inpatients receiving colorectal surgery from the department of surgery will be consecutively recruited in each surgical ward (namely, A4 ward, B4 ward and CD4 ward).
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03380169
Sponsor's protocol ID
61780111
Status last verified
Apr 2018
First submitted
2 Nov 2017
Last updated
11 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Field FK, Kerstein MD. Overview of wound healing in a moist environment. Am J Surg. 1994 Jan;167(1A):2S-6S. doi: 10.1016/0002-9610(94)90002-7.

    PubMed 8109679
  • Chen WY, Rogers AA, Lydon MJ. Characterization of biologic properties of wound fluid collected during early stages of wound healing. J Invest Dermatol. 1992 Nov;99(5):559-64. doi: 10.1111/1523-1747.ep12667378.

    PubMed 1431216

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic advance wound dressing and Prophylactic conventional wound dressing in people with Surgical Site Infection, run by Princess Margaret Hospital, Hong Kong at 1 site in Hong Kong.

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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. 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 Hong Kong. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chi Yeung Cheung, BSc (+85261780111, ccy542@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess if there are any surgical site infection on post-op day 30. (time frame: Post-op day 30). 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 NCT03380169, which also lists 2 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 11 Apr 2018.

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