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

NCT03380169 | Unknown

• 1 other identifier: 61780111
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (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.

  Post-op day 30

Secondary Outcomes (1)

• To assess if there are any surgical site infection on Post-op day 3 & 15.

  Post-op day 3 & 15

Study Arms (2)

Advance dressing

EXPERIMENTAL

Prophylactic advance wound dressing

Other: Prophylactic advance wound dressing

Conventional gauze dressing

ACTIVE COMPARATOR

Prophylactic conventional wound dressing

Other: Prophylactic conventional wound dressing

Interventions

Prophylactic advance wound dressing OTHER

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

Advance dressing

Prophylactic conventional wound dressing OTHER

Conventional gauze dressing

Conventional gauze dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or above undergo abdominal colorectal operation

You may not qualify if:

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

Sponsors & Collaborators

• Princess Margaret Hospital, Hong Kong: lead

Study Sites (1)

Princess Margaret Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

• 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.

  PMID: 8109679 BACKGROUND

• 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.

  PMID: 1431216 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi Yeung Cheung, BSc

  Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Yeung Cheung, BSc

CONTACT

+85261780111; ccy542@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients do not know which group they belongs to, and all wounds (for both experimental and control group) will be covered by gauze dressing at the top.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: 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).

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: December 21, 2017
• Study Start: October 15, 2017
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)