Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time (SAGRA)
Granulated Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time. Single-blind Randomized Clinical Trial
It is a randomized, single-blind clinical trial, whose population to be studied will be randomized patients with a diagnosis of dehiscence and infection of a cesarean surgical wound who meet the inclusion and exclusion criteria.
H0: Sucrose does not reduce hospital days in patients with surgical wound dehiscence.
HA: Sucrose reduces hospital days in patients with surgical wound dehiscence.
Study Overview
Status
Intervention / Treatment
Detailed Description
Cesarean section is one of the most performed surgical interventions at the Maternal and Child Hospital. Infection and dehiscence of the surgical site are some of the most common complications in post-cesarean section patients. The Honduran population, like those around the world, is susceptible to surgical site infections due to several risk factors and depends on each patient. Regarding the patients treated at the Maternal and Child Hospital, a surgical site risk of approximately 2-3% is estimated. Therefore, the investigators consider it beneficial to look for alternatives to treating surgical infections that help to reduce hospital time. Granulated sucrose has previously been used as a method for treating surgical wounds, however, no trial has been conducted to determine the benefits of its use.
Therefore, the investigators consider that it will be beneficial for the Gynecology and Obstetrics service of the Maternal and Child Hospital, especially the Septic ward, to carry out a study that helps to determine if the use of granulated sucrose reduces the hospitalization time of patients with infection and dehiscence of the surgical site due to cesarean section, as well as replacing the use of other methods that must be paid for by the patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Francisco Morazan
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Tegucigalpa, Francisco Morazan, Honduras, 11101
- Hospital Escuela
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Delivery of a signed and dated informed consent form.
- Declared willingness to comply with all study procedures and availability for the duration of the study.
- Women from 18 to 45 years old
- Enjoy good general health, as demonstrated by your medical history, and have been diagnosed with post-cesarean surgical wound dehiscence and fascia integra.
- Ability to take oral medication and be willing to comply with the sucrose regimen.
- Agreement to comply with Lifestyle Considerations
Exclusion Criteria:
- Known allergic reactions to sucrose components.
- Treatment with another investigational drug or other intervention within the previous 7 days.
- Current smoker or tobacco consumption within the previous 3 months.
- Treatment with antibiotics at least 2 weeks before hospitalization
Reinterventions before hospitalization
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
The surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap, then 75 g of sucrose will be administered to the surgical wound at 8:00 am every day, once a day, and then it will be covered with sterile gauze.
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surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap
75 g of sucrose will be administered to the surgical wound at 8:00 am every day, once a day, and then it will be covered with sterile gauze.
Other Names:
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Sham Comparator: Control
The surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap, once a day, and then covered with sterile gauze.
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surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes of in-hospital days
Time Frame: from the first intervention to delayed primary closure (by third intention), on average less than 14 days
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from the intervention days
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from the first intervention to delayed primary closure (by third intention), on average less than 14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of Satisfaction scale for scar assessment
Time Frame: 3 months
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Mesure with POSAS questionnaire (Patient and Observer Scar Assessment), The POSAS scale for the evaluation of scars is validated and shows advantages over other scales by integrating qualitative parameters and the opinion of the patient. It consists of six parameters to be evaluated on an ordinal scale from 1 to 10. The sum of all questions gives a final score (6 to 60 points). All items are rated on a scale ranging from 1 ("similar to normal skin") to 10 ("Very different from normal skin"). Less points means a better outcome. |
3 months
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Collaborators and Investigators
Investigators
- Study Director: Ricardo A. Gutierrez Ramirez, MD, MSc, Universidad Nacional Autonoma de Honduras
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGO-UNAH-47-2-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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