Surgical Wound InfectionNCT01846598
48 Hours After Surgery Shower Patient's Wound Infection Rate, Pain Score, Patient Satisfaction and Cost.
An observational study of Surgical Wound Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background and Purpose:The level of the surgical wound healing of the epidermis takes 6-12 hours, and the peak period of 48 hours to achieve healing.The traditional postoperative wound care was every 1-3 days clean with saline and gauze or other dressing and not opened .In traditional concept the wound touch the water… Read more about this study
- Who is it for?
- Ages 241 months and older
- Conditions the study is for
- Surgical Wound Infection
- How many people
- 444 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to Mar 2014
- How long will I take part?
- 14 Days
- Phase
- Observational
- 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 241 months and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult (minimum age> 20 years; maximum age are not limit) postoperative 48 hours suture not opened the line and remove the drainage tube of the wound (clean or clean contaminated wounds; the wound category 1,2)
Who may be able to join
- adult (minimum age> 20 years; maximum age are not limit) postoperative 48 hours suture not opened the line and remove the drainage tube of the wound (clean or clean contaminated wounds; the wound category 1,2)
Who cannot join
- surgical procedure contamination or have been infected wounds
- chronic wounds
- burns,wounds
- trauma wounds
- immune function insufficiency or use of immunosuppressive agents
- can not sign a consent form
- the end stage of disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 48 Hours After Surgery That Shower and Non-shower Patient's Wound Infection Rate, Pain Score, Patient Satisfaction and Cost.
Background and Purpose:The level of the surgical wound healing of the epidermis takes 6-12 hours, and the peak period of 48 hours to achieve healing.The traditional postoperative wound care was every 1-3 days clean with saline and gauze or other dressing and not opened .In traditional concept the wound touch the water that will increase the rate of wound infection.England Department of Health in 2008 surgical wound care guidelines about surgery wound cleaning solution comparison. It was no significant difference in wound infection.with normalsaline and tap water. 2012 The Cochrane Collaboration: Water for wound cleansing systematic review of the literature that wound clean water has no effect on the rate of wound infection and healing rate, conducive to personal hygiene and cost-effective. Under high temperature and humid environments in our country, after surgery not bathe often affect patients' satisfaction and increase the cost of dressing and manpower, Was opened a line after surgery the wound can be shower? It is important about surgical wound care guidelines, but also the patient daily asked a high degree of issues. Purpose of this study (1) post-operative 48 hours, shower or not wound infection rate (2) post-operative 48 hours, shower or not the pain score (3) post-operative 48 hours, shower or not the comfortable (4) post-operative 48 hours, shower or not the care costs.
Read the detailed description
Methods: In this study, adult patients postoperative 48 hours suture not opened the line and remove the drainage tube of the wound (clean or clean contaminated wounds; the wound category 1,2), single-blind randomized control study. Hospital Research Ethics Committee reviewed and approved, it is expected enrolled 102/04/22-102/12/30, a total of 444 cases, obtained in all cases informed consent form before operation, the case from the hospital Thoracic Surgery, General Surgery , thyroid surgery and orthopedic wards, outpatient closing the case.
Research situations and objects: the subjects conditions: adult (minimum age> 20 years; maximum age are not limit) 48 hours after surgery suture not opened the line and remove the drainage tube wound, closing the case exclusion conditions include: surgical procedure contamination or have been infected wounds, chronic wounds, burns,wounds, trauma wounds, immune function insufficiency or use of immunosuppressive agents can not sign a consent form by the end of the severe and pregnancy.
Research steps: meet the requirements of the subjects to obtain informed consent, by the number of computer random number table, randomly assigned into the shower group or non-shower group, n = 222, shower group will given leaflets before surgery about the wound care guidelines after surgery, (48 hours after surgery, shower not a bath so that your wounds will not be immersed in water, as this may reopen your wounds. please avoid the area of the wound. And gently on your stitches shower, do not vigorously rubbing the wound because it may cause pain,and might delayed wound healing after a rubbing, then with a clean towel and gently pat dry the wound.It can also be allowed to naturally dry or cool air from a hair dryer to dry, do no cover any dressing and maintain open and dry, do not use sanitizer. If shower during hospitalization advised and instructed by researchers. If shower during home, researchers advised and instructed by telephone interviews.The tap water single-use only, unlimited shower time and water amount. Non-shower group were given the current wound care guidance after surgery by the researchers before surgery (without dressing, after 48 hours use sterile normal saline solution clean the wound and cover with gauze, two days to be replaced once, but if sweating or other wet wound, can be replaced at any time.). All subjects returned to the clinic after 7-14 days, the researcher who do not know group will do the wound bacterial culture (if the wound appear red, swelling, heat, pain or purulent exudate or the original physician to determine the need),and the researcher also do outpatient surgical wound photographic archive for all subjects, photographic archive will be sent to an unknown group, MD, Department of Infectious Diseases to determine wound infection (1) or (2) or (3 ): (1) red, swelling, heat, pain (2) purulent exudate (3) bacterial culture (+) the wound track track record with experts validity postoperative.The collected data will Including basic information, the surgical site, surgical start and end times, the use of antibiotics situation, shower time, frequency, cost of water, pain conditions, Comfort, uncomfortable symptoms, surgical wound infection status assessment (skin around the wound redness, swelling, heat, pain, wound pus, exudate type and culture results), wound care costs and frequency. The version SPSS15.0 statistical software for archiving, and T-test ANOVA variance analysis, linear correlation analysis to analyze the data. Outcome measures: wound infection, pain condition, comfort, cost analysis.
- Conditions
- Surgical Wound Infection
- Medical subject headings
- Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
SURGICAL SITE INFECTION
Measured: 7-14 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 444 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsieh Pei-Yin, MSD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846598
- Sponsor's protocol ID
- 201301038RIND
- Status last verified
- Apr 2014
- First submitted
- 1 May 2013
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ. Water for wound cleansing. Cochrane Database Syst Rev. 2022 Sep 14;9(9):CD003861. doi: 10.1002/14651858.CD003861.pub4.
PubMed 36103365
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 48 Hours After Surgery That Shower and Non-shower Patient's Wound Infection Rate, Pain Score, Patient Satisfaction and Cost.
- ClinicalTrials.gov ID
- NCT01846598
- Acronym / sponsor ID
- 201301038RIND
- Conditions
- Surgical Wound Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Purpose:The level of the surgical wound healing of the epidermis takes 6-12 hours, and the peak period of 48 hours to achieve healing.The traditional postoperative wound care was every 1-3 days clean with saline and gauze or other dressing and not opened .In traditional concept the wound touch the water that will increase the rate of wound infection.England Department of Health in 2008 surgical wound care guidelines about surgery wound cleaning solution comparison. It was no significant difference in wound infection.with normalsaline and tap water. 2012 The Cochrane Collaboration: Water for wound cleansing systematic review of the literature that wound clean water has no effect on the rate of wound infection and healing rate, conducive to personal hygiene and cost-effective. Under high temperature and humid environments in our country, after surgery not bathe often affect patients' satisfaction and increase the cost of dressing and manpower, Was opened a line after surgery the wound can be shower? It is important about surgical wound care guidelines, but also the patient daily asked a high degree of issues. Purpose of this study (1) post-operative 48 hours, shower or not wound infection rate (2) post-operative 48 hours, shower or not the pain score (3) post-operative 48 hours, shower or not the comfortable (4) post-operative 48 hours, shower or not the care costs.
Detailed description
Methods: In this study, adult patients postoperative 48 hours suture not opened the line and remove the drainage tube of the wound (clean or clean contaminated wounds; the wound category 1,2), single-blind randomized control study. Hospital Research Ethics Committee reviewed and approved, it is expected enrolled 102/04/22-102/12/30, a total of 444 cases, obtained in all cases informed consent form before operation, the case from the hospital Thoracic Surgery, General Surgery , thyroid surgery and orthopedic wards, outpatient closing the case.
Research situations and objects: the subjects conditions: adult (minimum age> 20 years; maximum age are not limit) 48 hours after surgery suture not opened the line and remove the drainage tube wound, closing the case exclusion conditions include: surgical procedure contamination or have been infected wounds, chronic wounds, burns,wounds, trauma wounds, immune function insufficiency or use of immunosuppressive agents can not sign a consent form by the end of the severe and pregnancy.
Research steps: meet the requirements of the subjects to obtain informed consent, by the number of computer random number table, randomly assigned into the shower group or non-shower group, n = 222, shower group will given leaflets before surgery about the wound care guidelines after surgery, (48 hours after surgery, shower not a bath so that your wounds will not be immersed in water, as this may reopen your wounds. please avoid the area of the wound. And gently on your stitches shower, do not vigorously rubbing the wound because it may cause pain,and might delayed wound healing after a rubbing, then with a clean towel and gently pat dry the wound.It can also be allowed to naturally dry or cool air from a hair dryer to dry, do no cover any dressing and maintain open and dry, do not use sanitizer. If shower during hospitalization advised and instructed by researchers. If shower during home, researchers advised and instructed by telephone interviews.The tap water single-use only, unlimited shower time and water amount. Non-shower group were given the current wound care guidance after surgery by the researchers before surgery (without dressing, after 48 hours use sterile normal saline solution clean the wound and cover with gauze, two days to be replaced once, but if sweating or other wet wound, can be replaced at any time.). All subjects returned to the clinic after 7-14 days, the researcher who do not know group will do the wound bacterial culture (if the wound appear red, swelling, heat, pain or purulent exudate or the original physician to determine the need),and the researcher also do outpatient surgical wound photographic archive for all subjects, photographic archive will be sent to an unknown group, MD, Department of Infectious Diseases to determine wound infection (1) or (2) or (3 ): (1) red, swelling, heat, pain (2) purulent exudate (3) bacterial culture (+) the wound track track record with experts validity postoperative.The collected data will Including basic information, the surgical site, surgical start and end times, the use of antibiotics situation, shower time, frequency, cost of water, pain conditions, Comfort, uncomfortable symptoms, surgical wound infection status assessment (skin around the wound redness, swelling, heat, pain, wound pus, exudate type and culture results), wound care costs and frequency. The version SPSS15.0 statistical software for archiving, and T-test ANOVA variance analysis, linear correlation analysis to analyze the data. Outcome measures: wound infection, pain condition, comfort, cost analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 241 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult (minimum age> 20 years; maximum age are not limit) postoperative 48 hours suture not opened the line and remove the drainage tube of the wound (clean or clean contaminated wounds; the wound category 1,2)
Key inclusion criteria (1 listed)
- adult (minimum age> 20 years; maximum age are not limit) postoperative 48 hours suture not opened the line and remove the drainage tube of the wound (clean or clean contaminated wounds; the wound category 1,2)
Key exclusion criteria (8 listed)
- surgical procedure contamination or have been infected wounds
- chronic wounds
- burns,wounds
- trauma wounds
- immune function insufficiency or use of immunosuppressive agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SURGICAL SITE INFECTION
Time frame: 7-14 DAYS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Derived from this study: PubMed 36103365Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ. Water for wound cleansing. Cochrane Database Syst Rev. 2022 Sep 14;9(9):CD003861. doi: 10.1002/14651858.CD003861.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsieh Pei-Yin, MSD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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: finished, as of the sponsor's last update on 15 Apr 2014. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SURGICAL SITE INFECTION (time frame: 7-14 DAYS). 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 NCT01846598, which also lists 1 linked publication.
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 15 Apr 2014.