Clinical trial NCT06477770: Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time
Official title: Granulated Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time. Single-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Wound Infection
Cesarean Wound; Dehiscence
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Changes of in-hospital days
timeFrame: from the first intervention to delayed primary closure (by third intention), on average less than 14 days
Secondary outcomes:
measure: Change of Satisfaction scale for scar assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela
state: Francisco Morazan
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Ricardo A. Gutierrez Ramirez, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Li S, Renick P, Senkowsky J, Nair A, Tang L. Diagnostics for Wound Infections. Adv Wound Care (New Rochelle). 2021 Jun;10(6):317-327. doi: 10.1089/wound.2019.1103. Epub 2020 Jul 7.