Is Pressurized Irrigation an Effective Alternative to Swabbing for Wound Cleansing?
A Multicenter, Prospective, Randomised Controlled Trial to Compare the Pressurized Irrigation Method With Conventional Practice of Swabbing for Wound Cleansing
2 other identifiers
interventional
256
1 country
1
Brief Summary
The study is to examine the effectiveness of cleansing wound with pressurized irrigation method compared with conventional practice of swabbing on the wound healing and infection of acute and chronic wound, and to evaluate the patient's physical symptoms related to wound, patient's satisfaction to cleansing method, and cost of materials used between the two groups. Patients with acute or chronic non-sutured wounds as well as being eligible to exclusion criteria will be recruited and randomly assigned to be cleansed using either: pressurized irrigation method (experimental group) or swabbing method (control group). 244 patients will be recruited in the study. This will take place in four community health centres run by the Hospital Authority in Hong Kong. The wounds of participants will be cleansed using the assigned method for a six week period. The clinic staff nurse is responsible for the ongoing assessment of the wound. Wound assessment will be undertaken at enrolment and upon healing of the wound or at the end of six-week period if the wounds have not healed. Demographic data and information related to the wound -wound size +/- wound volume, wound culture swab, and symptoms -wound discomfort, pain and odour will be collected at enrolment. Information related to the wound and subjective measures of patient satisfaction -feeling of cleanliness, liking, and of staff satisfaction -feeling user-friendliness, accessibility, cleanliness, liking to the cleansing method using VAS will be assessed at completion of treatment. A list of cost measurements for the wound cleansing would also be captured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 20, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedJune 24, 2013
June 1, 2013
2.2 years
June 20, 2013
June 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time-to-wound healing
Complete healing is defined as complete coverage of the wound with epithelial tissue. Patient's wound that was observed to completely heal was referred for a wound check by second research nurse who was blinded to the intervention method. Healing time was indicated by number of days before complete skin integrity returned.
during the follow up within six-week period if the wounds have not yet healed
Secondary Outcomes (1)
infection rate during follow up
During follow up within six-week period if the wounds have not yet healed
Other Outcomes (1)
patient perceived wound symptoms
At enrolment and upon healing of the wound or at the end of six-week period if the wounds have not yet healed
Study Arms (2)
Pressurized irrigation method
EXPERIMENTALCleansing wound with pressurized irrigation technique using a pressurized irrigation device.
Swabbing wound cleansing method
ACTIVE COMPARATORAll patients in control group had wounds cleansed with swabbing technique using forceps and cotton wool (in sterile dressing pack), and received the 'standardized usual care'. Frequency of dressing change depended on the amount of exudates.
Interventions
The pressurized irrigation device is modified from using a special Syringe, connected to Gomco's Vacuum/Pressure Pump Model 309 that generate steady irrigation stream at pressure between 4 to 15 psi that is recommended to be safe and effective pressure for wound cleansing.
All patients in control group had wounds cleansed with swabbing technique using forceps and cotton wool (in sterile dressing pack)
Eligibility Criteria
You may qualify if:
- Had wounds to be healed by secondary intention,
- could speak Chinese,
- with an abbreviated mental test score 7 or above indicating their normal cognitive ability; and
- being able to be accessible for wound cleansing and evaluation follow up.
You may not qualify if:
- Unbroken skin;
- Full-thickness skin loss and damage to muscle, bone or/and any supporting structures (e.g. tendon, joint capsule);
- Wounds with a sinus where the base of the wound is not visible;
- Wounds to be healed by primary intention (e.g. sutured wound, skin grafts and skin-graft donor sites);
- Wound that was prescribed to be cleansed by irrigation;
- Patient with more than one wound;
- Patients with a very poor life expectancy or with a clinical condition that might interfere with wound healing such as active carcinoma, vasculitis, use of systemic corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within the past 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Territories East Cluster Nursing Hospital Authority
Hong Kong, China
Related Publications (1)
Mak SS, Lee MY, Cheung JS, Choi KC, Chung TK, Wong TW, Lam KY, Lee DT. Pressurised irrigation versus swabbing method in cleansing wounds healed by secondary intention: a randomised controlled trial with cost-effectiveness analysis. Int J Nurs Stud. 2015 Jan;52(1):88-101. doi: 10.1016/j.ijnurstu.2014.08.005. Epub 2014 Aug 22.
PMID: 25218264DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne So-Shan Mak, Master
Prince of Wales Hospital, Shatin, Hong Kong, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ms
Study Record Dates
First Submitted
June 20, 2013
First Posted
June 24, 2013
Study Start
April 1, 2008
Primary Completion
July 1, 2010
Study Completion
August 1, 2010
Last Updated
June 24, 2013
Record last verified: 2013-06