Surgical Site InfectionNCT03549702
Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section
A study testing Povidone iodine 1% solution in people with Surgical Site Infection, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the efficacy of Povidone Iodine (Betadine®) irrigation of subcutaneous tissue prior to skin closure in reducing the incidence of surgical site infection after elective caesarean section and post discharge. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Povidone iodine 1% solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 3 Mar 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: from 20 to 35 old years.
- Elective cesarean section.
- Caesarean section time from skin incision to skin closure less than 60 minutes.
- Preoperative Hemoglobin more than 10 gm /dl.
- Body Mass Index: 20_30 Kg/m2 .
Who cannot join
- Body Mass Index: <20 or >30 Kg/m2.
- Diabetic patient.
- Feverish patient.
- Patient using steroids for chronic illness.
- Hypertension chronic or with pregnancy.
- Prelabour rupture of membranes.
Show all 9Show fewer
- Difference in pre and postoperative hemoglobin more than 10%.
- Patients have a Coagulopathy disorder.
- Multiple pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section (Randomized Control Trial)
This study aims to assess the efficacy of Povidone Iodine (Betadine®) irrigation of subcutaneous tissue prior to skin closure in reducing the incidence of surgical site infection after elective caesarean section and post discharge.
Read the detailed description
All women will be counseled regarding mode of intervention and informed consent will be obtained. All women will be subjected to complete history taking, routine antenatal examination and investigations especially Hemoglobin test and 2 hour glucose tolerance test, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination.
Primary Outcome :
Surgical site infection up to 14 days following elective caesarian section.
Criteria of Surgical site infection:
Infection involves only skin and subcutaneous tissue of this incision. Occurs within 14 days after the operative procedure.
Includes at least one of the following:
- purulent drainage is present (culture documentation not required)
- organisms are isolated from fluid/tissue of the superficial incision
- at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
- the wound is deliberately opened by the surgeon
- the surgeon or clinician declares the wound infected.
Secondary Outcome :
- The need for secondary sutures closure of the infected wound after cleaning and debridement.
- The need for other doses of antibiotic rather than the preoperative prophylactic one.
- Postoperative fever exceeding 38.2, 24 hours following the caesarian section after exclusion of the other possible causes (eg: DVT, chest infections, Urinary tract infections).
- The duration of post operative hospital stay
- Coast effectiveness of hospital stay duration.
Randomization :
The study population will be randomly distributed according to the mode of intervention into 2 groups.
Randomization is performed using a Computer generated randomization system. Table of randomization is obtained.
Group 1 Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Nature of Povidone Iodine: It's a stable chemical complex of polyvinylpyrrolidone and elemental iodine.with chemical formula (C6H9I2NO).
Antiseptic properties: it's a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds, using the antiseptic properties of iodine.
Iodine has been recognized as an effective broad-spectrum bactericide, and is also effective against yeasts, molds, fungi, viruses, and protozoans.
In addition, it has been demonstrated that bacteria do not develop resistance to Povidone Iodine (Fleischer and Reimer, 1997).
Prophylactic 1gm of 3rd generation cephalosporins 30 minutes prior to skin incision.
The level of surgeon will be 2nd year residency or higher. Skin incision will be done by scalpel in Pfannenstiel manner. Subcutaneous tissue incision and division will be done using scalpel. Rectus sheath division will be done by scalpel with good hemostasis. Opening of the parietal peritoneum either sharp or blunt. Opening of the uterus in a C-shaped manner. Oxytocin 5 IU by slow intravenous injection will be used to encourage contraction of the uterus and to decrease blood loss.
The placenta will be removed using controlled cord traction and not manual removal.
Closure of the uterus in two continuous layers using polyglactin 910 No 1. Closure of parietal peritoneal. Closure of the rectus sheath in a continuous fashion using polyglactin 910 No1. Good hemostasis of subcutaneous tissue using the diathermy in coagulation mood. Irrigation of the subcutaneous tissue layers using povidone iodine using Betadine filled 20 cm syringe.
No insertion of subcutaneous tissue drain. No interrupted sutures in the skin. Approximating of the subcutaneous tissue using polyglactin 910 (2-0) if the tissue thickness more than 2 cm .
Closure of the skin using polypropylene (2-0) in subcuticular manner.
Group 2:
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.
Same steps as group 1 without subcutaneous tissue irrigation with Povidone iodine.
Allocation and Concealment 200 eligible women (who fulfill the inclusion and exclusion criteria) are to be randomly allocated into one of the two groups. Concealed allocation is adopted, however, in order to minimize selection bias. The allocated group numbers are concealed in serially-numbered opaque envelopes. Each envelope will contain the number of one of the two arms of the study, envelopes will be put in a box, and each woman under the study will pick one envelope which corresponds to the group to which she will be allocated. The envelopes are unsealed after recruitment of the cases.
- Conditions
- Surgical Site Infection
- Being tested
- Povidone iodine 1% solution
- 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.
Povidone iodine 1% solutionDrug
irrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure
| Study group | Role | What they receive |
|---|---|---|
| Povidone irrigation Group | Active comparator | Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution. Receives: Drug: Povidone iodine 1% solution |
| Control Group | No intervention | Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection up to 14 days following elective caesarian section.
- Infection involves only skin and subcutaneous tissue of this incision.
- Occurs within 14 days after the operative procedure.
- Includes at least one of the following:
- purulent drainage is present (culture documentation not required)
- organisms are isolated from fluid/tissue of the superficial incision
- at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
- the wound is deliberately opened by the surgeon
- the surgeon or clinician declares the wound infected.
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jan 2017
- Primary completion28 Feb 2018
- Study completion3 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Adel Azmy, Ain Shams University
- Investigators
- George Azmy, MBBCH, Principal investigator, Specialist of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549702
- Sponsor's protocol ID
- PovidIodCS
- Status last verified
- May 2018
- First submitted
- 9 Mar 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section (Randomized Control Trial)
- ClinicalTrials.gov ID
- NCT03549702
- Acronym / sponsor ID
- PovidIodCS
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 8 Jun 2018 (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.
This study aims to assess the efficacy of Povidone Iodine (Betadine®) irrigation of subcutaneous tissue prior to skin closure in reducing the incidence of surgical site infection after elective caesarean section and post discharge.
Detailed description
All women will be counseled regarding mode of intervention and informed consent will be obtained. All women will be subjected to complete history taking, routine antenatal examination and investigations especially Hemoglobin test and 2 hour glucose tolerance test, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination.
Primary Outcome :
Surgical site infection up to 14 days following elective caesarian section.
Criteria of Surgical site infection:
Infection involves only skin and subcutaneous tissue of this incision. Occurs within 14 days after the operative procedure.
Includes at least one of the following:
- purulent drainage is present (culture documentation not required)
- organisms are isolated from fluid/tissue of the superficial incision
- at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
- the wound is deliberately opened by the surgeon
- the surgeon or clinician declares the wound infected.
Secondary Outcome :
- The need for secondary sutures closure of the infected wound after cleaning and debridement.
- The need for other doses of antibiotic rather than the preoperative prophylactic one.
- Postoperative fever exceeding 38.2, 24 hours following the caesarian section after exclusion of the other possible causes (eg: DVT, chest infections, Urinary tract infections).
- The duration of post operative hospital stay
- Coast effectiveness of hospital stay duration.
Randomization :
The study population will be randomly distributed according to the mode of intervention into 2 groups.
Randomization is performed using a Computer generated randomization system. Table of randomization is obtained.
Group 1 Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Nature of Povidone Iodine: It's a stable chemical complex of polyvinylpyrrolidone and elemental iodine.with chemical formula (C6H9I2NO).
Antiseptic properties: it's a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds, using the antiseptic properties of iodine.
Iodine has been recognized as an effective broad-spectrum bactericide, and is also effective against yeasts, molds, fungi, viruses, and protozoans.
In addition, it has been demonstrated that bacteria do not develop resistance to Povidone Iodine (Fleischer and Reimer, 1997).
Prophylactic 1gm of 3rd generation cephalosporins 30 minutes prior to skin incision.
The level of surgeon will be 2nd year residency or higher. Skin incision will be done by scalpel in Pfannenstiel manner. Subcutaneous tissue incision and division will be done using scalpel. Rectus sheath division will be done by scalpel with good hemostasis. Opening of the parietal peritoneum either sharp or blunt. Opening of the uterus in a C-shaped manner. Oxytocin 5 IU by slow intravenous injection will be used to encourage contraction of the uterus and to decrease blood loss.
The placenta will be removed using controlled cord traction and not manual removal.
Closure of the uterus in two continuous layers using polyglactin 910 No 1. Closure of parietal peritoneal. Closure of the rectus sheath in a continuous fashion using polyglactin 910 No1. Good hemostasis of subcutaneous tissue using the diathermy in coagulation mood. Irrigation of the subcutaneous tissue layers using povidone iodine using Betadine filled 20 cm syringe.
No insertion of subcutaneous tissue drain. No interrupted sutures in the skin. Approximating of the subcutaneous tissue using polyglactin 910 (2-0) if the tissue thickness more than 2 cm .
Closure of the skin using polypropylene (2-0) in subcuticular manner.
Group 2:
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.
Same steps as group 1 without subcutaneous tissue irrigation with Povidone iodine.
Allocation and Concealment 200 eligible women (who fulfill the inclusion and exclusion criteria) are to be randomly allocated into one of the two groups. Concealed allocation is adopted, however, in order to minimize selection bias. The allocated group numbers are concealed in serially-numbered opaque envelopes. Each envelope will contain the number of one of the two arms of the study, envelopes will be put in a box, and each woman under the study will pick one envelope which corresponds to the group to which she will be allocated. The envelopes are unsealed after recruitment of the cases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone irrigation Group | Active comparator | Drug: Povidone iodine 1% solutionIncludes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution. |
| Control Group | No intervention | –Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age: from 20 to 35 old years.
- Elective cesarean section.
- Caesarean section time from skin incision to skin closure less than 60 minutes.
- Preoperative Hemoglobin more than 10 gm /dl.
- Body Mass Index: 20_30 Kg/m2 .
Key exclusion criteria (9 listed)
- Body Mass Index: <20 or >30 Kg/m2.
- Diabetic patient.
- Feverish patient.
- Patient using steroids for chronic illness.
- Hypertension chronic or with pregnancy.
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 |
|---|---|---|
| Povidone iodine 1% solutionirrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure | Drug | Povidone irrigation Group |
Primary outcome
Surgical site infection up to 14 days following elective caesarian section.
Time frame: 14 Days
* Infection involves only skin and subcutaneous tissue of this incision. * Occurs within 14 days after the operative procedure. * Includes at least one of the following: 1. purulent drainage is present (culture documentation not required) 2. organisms are isolated from fluid/tissue of the superficial incision 3. at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present. 4. the wound is deliberately opened by the surgeon 5. the surgeon or clinician declares the wound infected.
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 8 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
George Azmy, MBBCH principal investigator
Specialist of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone iodine 1% solution in people with Surgical Site Infection, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 9 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 8 Jun 2018. 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 Egypt. 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 up to 14 days following elective caesarian section. (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2018.