Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time

Not Applicable

Active, not recruiting

• Conditions: Surgical Wound Infection; Cesarean Wound; Dehiscence
• Interventions: Procedure: Clorhexidine soap; Other: Sucrose

• Registration Number: NCT06477770
• Lead Sponsor: Universidad Nacional Autonoma de Honduras

Brief Summary

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.

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 Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-06-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Delivery of a signed and dated informed consent form.
2. Declared willingness to comply with all study procedures and availability for the duration of the study.
3. Women from 18 to 45 years old
4. Enjoy good general health, as demonstrated by your medical history, and have been diagnosed with post-cesarean surgical wound dehiscence and fascia integra.
5. Ability to take oral medication and be willing to comply with the sucrose regimen.
6. Agreement to comply with Lifestyle Considerations

Exclusion Criteria

1. Known allergic reactions to sucrose components.

2. Treatment with another investigational drug or other intervention within the previous 7 days.

3. Current smoker or tobacco consumption within the previous 3 months.

4. Treatment with antibiotics at least 2 weeks before hospitalization

5. Reinterventions before hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Clorhexidine soap	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.
Intervention	Sucrose	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.
Control	Clorhexidine soap	The surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap, once a day, and then covered with sterile gauze.

Primary Outcome Measures

Name	Time	Method
Changes of in-hospital days	from the first intervention to delayed primary closure (by third intention), on average less than 14 days	from the intervention days

Secondary Outcome Measures

Name	Time	Method
Change of Satisfaction scale for scar assessment	3 months	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.

Trial Locations

Locations (1)

Hospital Escuela; 🇭🇳 Tegucigalpa, Francisco Morazan, Honduras