Is Pressurized Irrigation an Effective Alternative to Swabbing for Wound Cleansing?
Is Pressurized Irrigation an Effective Alternative to Swabbing for Wound Cleansing?
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.
- Registration/ randomization procedure:

 Once patients are identified as potential participants at their outpatient clinic visit, the
 research nurse will initiate the enrolment process by explaining the objectives of the
 proposed study to the patient. Informed consents are obtained for eligible subjects. A
 thorough assessment and measurement of the wound will be done by another research nurse.
 Participants are asked to complete the first questionnaire. Participants are then randomized
 to either intervention or control group. Randomization will be done by a randomization list
 generated by a statistician using a simple randomization method and programmed in a
 designated computer.

 - Schema of intervention delivery and data collection:

 The wounds of participants in control group and study group will be cleansed following to the
 allocated method until the wounds are completely healed or for six weeks if the wounds have
 not yet healed. Wound-care specialists and microbiologists will be consulted throughout the
 study for technical advice, particularly on information not readily available in the
 literature. Decisions relating to the time period needed to detect wound infection and
 healing, as well as the investigations required to detect wound infection, are made in
 consultation with this group.

 The first research nurse will undertake wound cleansing for experimental group. Wound
 cleansing in control group is done as usual by the staff nurses in the four designated
 clinics, who will attend an education programme which explains the details of the study, the
 procedures to be followed, and the patient documentation. The first research nurse and the
 clinic nurse who undertakes dressing change are responsible for the ongoing assessment of the
 wound during cleansing and recording the information on the volume of solution and amount of
 cleansing materials used, frequency of dressing changes and the type of dressing applied at
 each visit. Participants are instructed to report any signs of infection to the first
 research nurse and the clinic nurse or physician. The second research nurse who is blinded to
 the wound cleansing method will undertake data collection and wound assessment for all
 subjects at enrollment and upon healing of the wound or at the end of six-week period if the
 wounds have not yet healed. Wounds that have not healed at the end of the six-week period
 will be reassessed and data relating to the wound characteristics are recorded.

 - Criteria for study discontinuation:

 Participants may be discontinued from the study and assessments at any time. Criteria of
 premature withdrawal from trial include 1) Voluntary discontinuation by the participants
 without prejudice to further care; 2) Participants lost to follow up. For withdrawal from
 trial treatment: 1) Any surgical intervention to the wounds as required; 2) Safety reasons as
 judged by investigator; 3) Severe non compliance to the protocol as judged by the
 investigator, these patients will be followed to trial completion. Investigators should
 document the reasons for withdrawal in patient notes. The decision of withdrawal would not
 affect further wound care management.

 - Statistical analysis:

 The time to wound-healing is analyzed using Cox regression analysis. An intent-to-treat
 principle will be applied in the analysis. Patients' time-to-wound-healing are censored at
 the time of consent withdrawal, dead or lost to follow up. The difference between the two
 arms is assessed using Cox model. Repeated measures ANOVA is performed to compare the effects
 of intervention (vs. control) and time (6 week post randomization) on mean wound size change.
 The differences in wound symptoms and patient's satisfaction and comfort to cleansing method
 are analyzed using Wilcoxon Rank Sum Test. Chi-square test is used to test difference in the
 infection incidence and the proportion of wounds completely healed during follow up between
 the two groups. Prognostic factors are assessed and adjusted using a Cox proportional hazard
 regression model. These variables are: age, body mass index (calculated from participants'
 height and weight), wound characteristics (location, types, wound size), wound status
 (assessed by Wound Status Assessment score), smoking, presence of underlying disease,
 concomitant medication and mental status (assessed by AMT).

 - Recruitment schedule:

 For the purpose of easy operation and avoiding too many patients accumulated at the same
 time, recruitment will be done separately in 10 cycles. The first research nurse need to
 perform wound dressing in experimental group for 2 patients per hour, thus 12-13 patients a
 day. It will be stopped as soon as 26 patients are recruited in the first week of each cycle
 so as to facilitate spreading the attending time of patients in the coming 6-week wound
 cleansing visits, therefore they do not need to wait long. That means it takes 2 months to
 accomplish recruitment plus 6 weeks wound cleansing and data collection for 24-26 subjects,
 therefore 20 months is required for 244 subjects. It is envisaged that the study will take 24
 months.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.