Postoperative Wound Infection
Conditions
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
Brief 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 (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.
Interventions
OTHERPlain soap and water (PSW)
Presence or absence of infection
OTHERAlcohol-based hand rub (ABHR)
Presence or absence of infection
Sponsors
World Health Organization
AIC Kijabe Hospital
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Hand Preparation Agent | 30 days | 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. |
Countries
Kenya
Participant flow
Recruitment details
Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007
Pre-assignment details
Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.
Participants by arm
| Arm | Count |
|---|---|
| Plain Soap and Water Surgical hand preparation with plain soap and water | 1,682 |
| Alcohol Based Hand Rubs Surgical hand preparation with alcohol based alcohol hand rub | 1,635 |
| Total | 3,317 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Insufficient data entry | 86 | 98 |
Baseline characteristics
| Characteristic | Plain Soap and Water | Alcohol Based Hand Rubs | Total |
|---|---|---|---|
| Age Continuous | 28 Participants STANDARD_DEVIATION 23 | 29 Participants STANDARD_DEVIATION 19 | 29 Participants STANDARD_DEVIATION 22 |
| Region of Enrollment Kenya | 1682 participants | 1635 participants | 3317 participants |
| Sex: Female, Male Female | 964 Participants | 908 Participants | 1872 Participants |
| Sex: Female, Male Male | 718 Participants | 727 Participants | 1445 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,596 | 0 / 1,537 |
| serious Total, serious adverse events | 0 / 1,596 | 0 / 1,537 |
Outcome results
Primary
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).
Time frame: 30 days post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plain Soap and Water | Surgical Site Infection | 128 Participants |
| Alcohol Based Hand Rubs | Surgical Site Infection | 127 Participants |
Comparison: Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.p-value: <0.05generalized estimating equation
Secondary
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.
Time frame: 30 days