Wound InfectionNCT02868372
Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
A study testing Povidone iodine in people with Wound Infection, run by Assiut University.
Trial summary
The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical… Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Wound Infection
- What is being tested?
- Povidone iodine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Apr 2017
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women having either first time or repeat cesarean section whether elective or emergency.
Who cannot join
- Women with prolonged rupture of membranes more than 12 hours.
- Women with morbid obesity with BMI>35.
- Women with diabetes, hypertension or anemia with hemoglobin<9.
- Women on corticosteroid therapy or immunosuppressed women.
- Women with intraoperative hemorrhage or hematoma formation.
- Women allergic to betadine.
- The cesarean section which duration exceed one hour or associated with other surgical procedure.
About this study
Official title: The Efficacy of Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine to Prevent Postoperative Wound Infection: A Randomized Controlled Clinical Trial
The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
Read the detailed description
Aim of the study:
To assess the efficacy of subcutaneous swabbing of cesarean section wounds with povidone iodine to prevent postoperative wound infection.
Study Design: Randomized controlled trial.
Subjects: Women having a cesarean delivery.
The women will have a full description of the study and Subjects will be randomized by selecting a sequentially numbered sealed envelope to one of each group which will be opened during closure of rectus sheath.
Method :
- Patient will receive single dose of prophylactic antibiotic (2-grams first generation cephalosporin) intravenous at time of cesarean delivery during induction of anesthesia. -The same type of suturing material; vicryl No1 will be used for rectus Sheath repair in both groups.
- The same type of suturing material will be used to suture the subcutaneous tissue and the skin (vicryl NO 2/0).
Follow up : Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
Outcome :The study outcome is to detect and record the incidence of surgical wound infection in both groups.It is a composite outcome with presence of any of the following is considered infection:
- Induration
- Swelling of the wound edges
- Discharge of pus or wound dehiscence.
- Purulent drainage with or without laboratory confirmation, from the superficial incision
- Pain or tenderness with redness, or heat
- Superficial incision being deliberately opened by surgeon.
Sample size estimation:
It was calculated that 269 patients are required in each arm to detect a 5% reduction (from 7% to 2%) in cesarean section wound infection rates between study and control groups.
Statistical Analysis:
Data will be tabulated using Statistical Package for Social Scientists (SPSS) program and statistical analysis will be carried out with suitable statistical tests. Continuous variables will be presented as mean and standard deviation, and will be compared using Student-t-test. Dichotomous variables will be compared using Chi square and the cut off point for P-value will be less than 0.05.
- Conditions
- Wound Infection
- Being tested
- Povidone iodine
- Keywords
- Cesarean section, Betadine, Wound infection
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone iodineDrug
Also called Betadine
After closure of the anterior wall of the rectus sheath, the subcutaneous tissues of the cesarean section wound will be swabbed with 10% undiluted Povidone iodine without mobbing.
| Study group | Role | What they receive |
|---|---|---|
| Betadine group | Active comparator | Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues Receives: Drug: Povidone iodine |
| No intervention group | No intervention | No swabbing of subcutaneous tissue of cesarean section wounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect and record the incidence of surgical wound infection in both groups
: Women in both groups will be followed up during hospital stay and outpatient clinic visit for one month after cesarean delivery for surgical site complications which will be evaluated by the researcher
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Rashad Abdel-Hafeez Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868372
- Sponsor's protocol ID
- AUH2
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine to Prevent Postoperative Wound Infection: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02868372
- Acronym / sponsor ID
- AUH2
- Conditions
- Wound Infection
- Keywords
- Cesarean section, Betadine, Wound infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 16 Aug 2016 (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.
The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
Detailed description
Aim of the study:
To assess the efficacy of subcutaneous swabbing of cesarean section wounds with povidone iodine to prevent postoperative wound infection.
Study Design: Randomized controlled trial.
Subjects: Women having a cesarean delivery.
The women will have a full description of the study and Subjects will be randomized by selecting a sequentially numbered sealed envelope to one of each group which will be opened during closure of rectus sheath.
Method :
- Patient will receive single dose of prophylactic antibiotic (2-grams first generation cephalosporin) intravenous at time of cesarean delivery during induction of anesthesia. -The same type of suturing material; vicryl No1 will be used for rectus Sheath repair in both groups.
- The same type of suturing material will be used to suture the subcutaneous tissue and the skin (vicryl NO 2/0).
Follow up : Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
Outcome :The study outcome is to detect and record the incidence of surgical wound infection in both groups.It is a composite outcome with presence of any of the following is considered infection:
- Induration
- Swelling of the wound edges
- Discharge of pus or wound dehiscence.
- Purulent drainage with or without laboratory confirmation, from the superficial incision
- Pain or tenderness with redness, or heat
- Superficial incision being deliberately opened by surgeon.
Sample size estimation:
It was calculated that 269 patients are required in each arm to detect a 5% reduction (from 7% to 2%) in cesarean section wound infection rates between study and control groups.
Statistical Analysis:
Data will be tabulated using Statistical Package for Social Scientists (SPSS) program and statistical analysis will be carried out with suitable statistical tests. Continuous variables will be presented as mean and standard deviation, and will be compared using Student-t-test. Dichotomous variables will be compared using Chi square and the cut off point for P-value will be less than 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betadine group | Active comparator | Drug: Povidone iodineSubcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues |
| No intervention group | No intervention | –No swabbing of subcutaneous tissue of cesarean section wounds |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women having either first time or repeat cesarean section whether elective or emergency.
Key exclusion criteria (7 listed)
- Women with prolonged rupture of membranes more than 12 hours.
- Women with morbid obesity with BMI>35.
- Women with diabetes, hypertension or anemia with hemoglobin<9.
- Women on corticosteroid therapy or immunosuppressed women.
- Women with intraoperative hemorrhage or hematoma formation.
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 iodineAlso: BetadineAfter closure of the anterior wall of the rectus sheath, the subcutaneous tissues of the cesarean section wound will be swabbed with 10% undiluted Povidone iodine without mobbing. | Drug | Betadine group |
Primary outcome
Detect and record the incidence of surgical wound infection in both groups
Time frame: One month
: Women in both groups will be followed up during hospital stay and outpatient clinic visit for one month after cesarean delivery for surgical site complications which will be evaluated by the researcher
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone iodine in people with Wound Infection, run by Assiut University.
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 7 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: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Detect and record the incidence of surgical wound infection in both groups (time frame: One month). 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 16 Aug 2016.