AntisepsisNCT05896462
Effect of Skin Antisepsis After Skin Closure on Wound Infection After Abdominal Surgery for Sepsis: a Preliminary Report
A study testing 10% povidone iodine in people with Antisepsis, run by Ikechukwu Bartholomew Ulasi at 1 site in Nigeria.
Trial summary
The benefits of pre-incision skin antisepsis is well established. However, the role of skin antisepsis after skin closure in abdominal surgery for sepsis is not well reported. This study examined whether the use of skin antisepsis after closing the skin during a surgery for an infection within the abdomen would have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antisepsis
- What is being tested?
- 10% povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNigeria
- Study dates
- 19 Aug 2019to 29 Mar 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring laparotomy for sepsis aged 18 years and above
Who cannot join
- All cases of clean and clean-contaminated abdominal surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Skin Antisepsis After Primary Skin Closure on the Incidence of Surgical Site Infection After Abdominal Surgery for Sepsis: a Preliminary Report of a Randomized Controlled Trial
The benefits of pre-incision skin antisepsis is well established. However, the role of skin antisepsis after skin closure in abdominal surgery for sepsis is not well reported. This study examined whether the use of skin antisepsis after closing the skin during a surgery for an infection within the abdomen would have an effect on wound infection in the post-operative period. The patients - aged 18 years and above - were categorised into two groups: the first had antisepsis with povidone iodine-soaked gauze while the second group of patients had their wound only dressed with a dry sterile gauze. Both groups were then compared for the occurrence of surgical site infection and other post-operative outcomes. The null hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have no effect on the incidence of post-operative Surgical Site Infection while the alternative hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have an effect on the incidence of post-operative Surgical Site Infection.
Read the detailed description
The beneficial role of this pre-operative skin preparation has been fully established in several studies, persisting debate being essentially limited to which agent or combination of agents provides superior antiseptic benefit.
However, following skin closure after abdominal surgery, and cleaning the wound edges and surrounding skin of blood and other tissue fluid with a soapy antiseptic agent, some surgeons clean the apposed skin edge with an antiseptic solution, either isopropyl alcohol (more commonly) or povidone-iodine, before application of sterile dressings. The effects of this practice after skin closure in terms of post-operative wound outcome remains to be established. This was a prospective randomized controlled study conducted at the University College Hospital Ibadan, Nigeria. Study participants were recruited from adult patients presenting through the Surgery Out-Patient (SOP) department, Emergency departments and non-surgical wards of University College Hospital, Ibadan. Assuming a standard normal deviate at 5% type I error of 1.96, power of 80%, an SSI prevalence of 38.1% in the control group10 with 15% degree of precision, a total sample size of 84 patients were obtained, having considered an attrition rate of 5%. This preliminary report is based on 37 patients recruited so far.
. Study participants were randomized into 2 groups: povidone iodine (PI) \& Control (C) groups using blocked sequence randomization. Consecutive adult surgical patients (aged 18 years and above) booked to have abdominal surgery for sepsis were prospectively enrolled in turns into the two study groups.
Shaving of abdominal hair was done for all patients just before the surgery using a surgical blade. They were given a single dose each of intravenous ceftriaxone (1g; Zonon; Sanofi;) and metronidazole (500mg; Metrone; Aventra) at the induction of anaesthesia. After surgery, patients with contaminated wounds were given intravenous ceftriaxone and metronidazole, discontinued after 24hours post-operatively. Patients with dirty wounds received therapeutic doses of post-operative antibiotics intravenously (iv ceftriaxone 1 g 12hourly and iv metronidazole 500mg 8hourly) for 10-14days. This was converted to oral antibiotics (cefpodoxime 200mg 12hourly and metronidazole 500mg 8hourly) once oral intake was established.
Skin preparation was done as follows: scrubbing of the operation site twice over 3-5 minutes using savlon (0.3% chlorhexidine-gluconate in alcohol + 3% cetrimide) was followed by drying of the skin with a sterile gauze. The operation site was painted with 10% povidone iodine followed by 70% isopropyl alcohol before draping. A midline incision that provides adequate exposure was made using a scalpel and deepened using monopolar diathermy. Upon gaining peritoneal access, a wound swab was taken from the focus of peritoneal contamination/sepsis. The surgical procedures relevant for each case was carried out.
Having closed the skin and cleaned with savlon and 70% isopropyl alcohol, patients in the C group had the apposed skin edge covered with dry sterile gauze while in PI group, 10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge. The surgical site was assessed on the 3rd, 7th and 10th post-operative day for evidence of SSI, defined in this study as purulent drainage from the surgical wound or a drain inserted at surgery.
A swab was taken from the wound edge of all patients with a clinical feature of SSI using a sterile swab stick for microscopy, culture and sensitivity. The type of intervention, type and duration of post-operative antibiotics and other relevant information were documented in an identifier-free patient's proforma. The total duration of hospital stay, calculated from the first post-operative day to the day of discharge, was recorded.
Comparison of groups for surgical site infection was done using the Pearson's Chi-square (X2) test. Multivariate logistic regression analysis was used to test for significance of association between potentially confounding variables and the development of SSI. Statistical significance was set at a p-value of <0.05 and Confidence Interval of 95%. Version 23 of the Statistical Package for Social Sciences for Windows (SPSS Inc. Il, USA) was used to analyze all data obtained from the study
- Conditions
- Antisepsis
- Being tested
- 10% povidone iodine
- Keywords
- Antisepsis, Skin Closure, Abdominal Surgery, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% povidone iodineOther
The apposed skin edge was covered with 10% povidone iodine-soaked gauze dressing
| Study group | Role | What they receive |
|---|---|---|
| Povidone iodine (PI) group | Active comparator | 10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge. Receives: Other: 10% povidone iodine |
| Control (C) group | No intervention | The apposed skin edge covered with dry sterile gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI (Surgical Site Infection)
Incidence of surgical site infection
Measured: From day 3 post-operatively up to 28 days post-operatively
Secondary outcomes (1)
LOS (Length of Stay)
Duration of hospital stay
Measured: From day 1 post-operatively up to the day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start19 Aug 2019
- Primary completion1 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AntisepsisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Having closed the skin and cleaned with savlon and 70% isopropyl alcohol, patients in the C group had the apposed skin edge covered with dry sterile gauze while in PI group, 10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ikechukwu Bartholomew Ulasi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ikechukwu Bartholomew Ulasi, University College Hospital, Ibadan
- Investigators
- Ikechukwu B. Ulasi, Principal investigator, University College Hospital, Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896462
- Sponsor's protocol ID
- UI/EC/19/0158
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maiwald M, Chan ES. The forgotten role of alcohol: a systematic review and meta-analysis of the clinical efficacy and perceived role of chlorhexidine in skin antisepsis. PLoS One. 2012;7(9):e44277. doi: 10.1371/journal.pone.0044277. Epub 2012 Sep 5.
PubMed 22984485Reichel M, Heisig P, Kohlmann T, Kampf G. Alcohols for skin antisepsis at clinically relevant skin sites. Antimicrob Agents Chemother. 2009 Nov;53(11):4778-82. doi: 10.1128/AAC.00582-09. Epub 2009 Sep 8.
PubMed 19738017Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.
PubMed 23543526Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.
PubMed 23859304
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Skin Antisepsis After Primary Skin Closure on the Incidence of Surgical Site Infection After Abdominal Surgery for Sepsis: a Preliminary Report of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05896462
- Acronym / sponsor ID
- UI/EC/19/0158
- Conditions
- Antisepsis
- Keywords
- Antisepsis, Skin Closure, Abdominal Surgery, Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ikechukwu Bartholomew UlasiUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 9 Jun 2023 (actual)
- 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.
The benefits of pre-incision skin antisepsis is well established. However, the role of skin antisepsis after skin closure in abdominal surgery for sepsis is not well reported. This study examined whether the use of skin antisepsis after closing the skin during a surgery for an infection within the abdomen would have an effect on wound infection in the post-operative period. The patients - aged 18 years and above - were categorised into two groups: the first had antisepsis with povidone iodine-soaked gauze while the second group of patients had their wound only dressed with a dry sterile gauze. Both groups were then compared for the occurrence of surgical site infection and other post-operative outcomes. The null hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have no effect on the incidence of post-operative Surgical Site Infection while the alternative hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have an effect on the incidence of post-operative Surgical Site Infection.
Detailed description
The beneficial role of this pre-operative skin preparation has been fully established in several studies, persisting debate being essentially limited to which agent or combination of agents provides superior antiseptic benefit.
However, following skin closure after abdominal surgery, and cleaning the wound edges and surrounding skin of blood and other tissue fluid with a soapy antiseptic agent, some surgeons clean the apposed skin edge with an antiseptic solution, either isopropyl alcohol (more commonly) or povidone-iodine, before application of sterile dressings. The effects of this practice after skin closure in terms of post-operative wound outcome remains to be established. This was a prospective randomized controlled study conducted at the University College Hospital Ibadan, Nigeria. Study participants were recruited from adult patients presenting through the Surgery Out-Patient (SOP) department, Emergency departments and non-surgical wards of University College Hospital, Ibadan. Assuming a standard normal deviate at 5% type I error of 1.96, power of 80%, an SSI prevalence of 38.1% in the control group10 with 15% degree of precision, a total sample size of 84 patients were obtained, having considered an attrition rate of 5%. This preliminary report is based on 37 patients recruited so far.
. Study participants were randomized into 2 groups: povidone iodine (PI) \& Control (C) groups using blocked sequence randomization. Consecutive adult surgical patients (aged 18 years and above) booked to have abdominal surgery for sepsis were prospectively enrolled in turns into the two study groups.
Shaving of abdominal hair was done for all patients just before the surgery using a surgical blade. They were given a single dose each of intravenous ceftriaxone (1g; Zonon; Sanofi;) and metronidazole (500mg; Metrone; Aventra) at the induction of anaesthesia. After surgery, patients with contaminated wounds were given intravenous ceftriaxone and metronidazole, discontinued after 24hours post-operatively. Patients with dirty wounds received therapeutic doses of post-operative antibiotics intravenously (iv ceftriaxone 1 g 12hourly and iv metronidazole 500mg 8hourly) for 10-14days. This was converted to oral antibiotics (cefpodoxime 200mg 12hourly and metronidazole 500mg 8hourly) once oral intake was established.
Skin preparation was done as follows: scrubbing of the operation site twice over 3-5 minutes using savlon (0.3% chlorhexidine-gluconate in alcohol + 3% cetrimide) was followed by drying of the skin with a sterile gauze. The operation site was painted with 10% povidone iodine followed by 70% isopropyl alcohol before draping. A midline incision that provides adequate exposure was made using a scalpel and deepened using monopolar diathermy. Upon gaining peritoneal access, a wound swab was taken from the focus of peritoneal contamination/sepsis. The surgical procedures relevant for each case was carried out.
Having closed the skin and cleaned with savlon and 70% isopropyl alcohol, patients in the C group had the apposed skin edge covered with dry sterile gauze while in PI group, 10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge. The surgical site was assessed on the 3rd, 7th and 10th post-operative day for evidence of SSI, defined in this study as purulent drainage from the surgical wound or a drain inserted at surgery.
A swab was taken from the wound edge of all patients with a clinical feature of SSI using a sterile swab stick for microscopy, culture and sensitivity. The type of intervention, type and duration of post-operative antibiotics and other relevant information were documented in an identifier-free patient's proforma. The total duration of hospital stay, calculated from the first post-operative day to the day of discharge, was recorded.
Comparison of groups for surgical site infection was done using the Pearson's Chi-square (X2) test. Multivariate logistic regression analysis was used to test for significance of association between potentially confounding variables and the development of SSI. Statistical significance was set at a p-value of <0.05 and Confidence Interval of 95%. Version 23 of the Statistical Package for Social Sciences for Windows (SPSS Inc. Il, USA) was used to analyze all data obtained from the study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Having closed the skin and cleaned with savlon and 70% isopropyl alcohol, patients in the C group had the apposed skin edge covered with dry sterile gauze while in PI group, 10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge
| Arm | Type | Receives |
|---|---|---|
| Povidone iodine (PI) group | Active comparator | Other: 10% povidone iodine10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge. |
| Control (C) group | No intervention | –The apposed skin edge covered with dry sterile gauze |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients requiring laparotomy for sepsis aged 18 years and above
Key exclusion criteria (1 listed)
- All cases of clean and clean-contaminated abdominal surgeries
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 |
|---|---|---|
| 10% povidone iodineThe apposed skin edge was covered with 10% povidone iodine-soaked gauze dressing | Other | Povidone iodine (PI) group |
Primary outcome
SSI (Surgical Site Infection)
Time frame: From day 3 post-operatively up to 28 days post-operatively
Incidence of surgical site infection
1 secondary outcome
LOS (Length of Stay)
Time frame: From day 1 post-operatively up to the day of discharge
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 9 Jun 2023.
- Background: PubMed 22984485Maiwald M, Chan ES. The forgotten role of alcohol: a systematic review and meta-analysis of the clinical efficacy and perceived role of chlorhexidine in skin antisepsis. PLoS One. 2012;7(9):e44277. doi: 10.1371/journal.pone.0044277. Epub 2012 Sep 5.
- Background: PubMed 19738017Reichel M, Heisig P, Kohlmann T, Kampf G. Alcohols for skin antisepsis at clinically relevant skin sites. Antimicrob Agents Chemother. 2009 Nov;53(11):4778-82. doi: 10.1128/AAC.00582-09. Epub 2009 Sep 8.
- Background: PubMed 23543526Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.
- Background: PubMed 23859304Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.
- Individual participant dataSharing planned: No
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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.
Ikechukwu B. Ulasi principal investigator
University College Hospital, Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% povidone iodine in people with Antisepsis, run by Ikechukwu Bartholomew Ulasi at 1 site in Nigeria.
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 1 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 9 Jun 2023. 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 Nigeria. 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?
SSI (Surgical Site Infection) (time frame: From day 3 post-operatively up to 28 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 NCT05896462, which also lists 4 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 9 Jun 2023.