Postoperative Wound InfectionPhase 1/2NCT00987402
Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
A Phase 1/2 study testing Plain soap and water (PSW) and Alcohol-based hand rub (ABHR) in people with Postoperative Wound Infection, run by University Hospital, Geneva at 1 site in Kenya.
Trial summary
Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Wound Infection
- What is being tested?
- Plain soap and water (PSW) and Alcohol-based hand rub (ABHR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,317 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2007to Nov 2007
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital
Who cannot join
- All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
- Patients who did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.
A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
- Conditions
- Postoperative Wound Infection
- Being tested
- Plain soap and water (PSW), Alcohol-based hand rub (ABHR)
- Keywords
- Surgery, hand scrubbing, post-operative infection, surgical site infection, surgical hand preparation, plain soap and water, alcohol-based hand rub, Cost of surgical hand preparation agent, Side effects of use of hand preparation agent
- 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.
Plain soap and water (PSW)Other
Also called Plain bar soap, WHO recommended alcohol based hand rub formulation II
Presence or absence of infection
Alcohol-based hand rub (ABHR)Other
Presence or absence of infection
| Study group | Role | What they receive |
|---|---|---|
| Plain soap and water | Active comparator | Surgical hand preparation with plain soap and water Receives: Other: Plain soap and water (PSW) |
| Alcohol based hand rubs | Active comparator | Surgical hand preparation with alcohol based alcohol hand rub Receives: Other: Alcohol-based hand rub (ABHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).
Measured: 30 days post-operatively
Secondary outcomes (1)
Cost of Hand Preparation Agent
Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Wound InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, AIC Kijabe Hospital
- Investigators
- Peter M Nthumba, MD, Principal investigator, AIC Kijabe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987402
- Sponsor's protocol ID
- KH-PSW-ABHR
- Status last verified
- Nov 2009
- First submitted
- 30 Sep 2009
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x.
PubMed 22297835Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213.
PubMed 20878941
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
- ClinicalTrials.gov ID
- NCT00987402
- Acronym / sponsor ID
- KH-PSW-ABHR
- Conditions
- Postoperative Wound Infection
- Keywords
- Surgery, hand scrubbing, post-operative infection, surgical site infection, surgical hand preparation, plain soap and water, alcohol-based hand rub, Cost of surgical hand preparation agent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,317 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- World Health Organization, AIC Kijabe Hospital
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.
A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain soap and water | Active comparator | Other: Plain soap and water (PSW)Surgical hand preparation with plain soap and water |
| Alcohol based hand rubs | Active comparator | Other: Alcohol-based hand rub (ABHR)Surgical hand preparation with alcohol based alcohol hand rub |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital
Key exclusion criteria (2 listed)
- All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
- Patients who did not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plain soap and water (PSW)Also: Plain bar soap, WHO recommended alcohol based hand rub formulation IIPresence or absence of infection | Other | Plain soap and water |
| Alcohol-based hand rub (ABHR)Presence or absence of infection | Other | Alcohol based hand rubs |
Primary outcome
Surgical Site Infection
Time frame: 30 days post-operatively
255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).
1 secondary outcome
Cost of Hand Preparation Agent
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22297835Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x.
- Derived from this study: PubMed 20878941Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213.
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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.
Peter M Nthumba, MD principal investigator
AIC Kijabe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plain soap and water (PSW) and Alcohol-based hand rub (ABHR) in people with Postoperative Wound Infection, run by University Hospital, Geneva at 1 site in Kenya.
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 2 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 21 Aug 2012. 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 Kenya. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 30 days post-operatively). 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 NCT00987402, 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 21 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.