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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylaxis of Surgical Wound Infection With Topical Antibiotics

NCT04476212

Surgical Site Infection Surgery--Complications Colorectal Surgery +2 more

UNKNOWN NA

Cosmetic Results With Tissue Adhesive vs. Subdermal Sutures in Cesarean Section

NCT06760026

Cesarean Wound Repair Cesarean Section Scar Cosmetic Appearance of Cesarean Scar +1 more

RECRUITING NA

Wound Healing of Incisional Wounds for Bilateral Hernia Repair

NCT01008111

Wound Healing

WITHDRAWN PHASE1

Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies

NCT02832076

Postoperative Wound Healing

COMPLETED NA

Irrigation and Suction Trial to Prevent SSI

NCT05611944

Surgical Site Infection Diabete Mellitus Abdominal Hysterectomy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Wound Infection Cesarean Wound; Dehiscence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Both the patients and 3 researchers will know the intervention, however, the groups will be listed and during the analysis phase, the analyst researcher will not know which group each patient corresponds to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Clorhexidine soap

Intervention Type PROCEDURE

surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap

Sucrose

Intervention Type OTHER

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

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

Group Type SHAM_COMPARATOR

Clorhexidine soap

Intervention Type PROCEDURE

surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clorhexidine soap

surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap

Intervention Type PROCEDURE

Sucrose

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 Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

saccharose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes