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OpenTrials
Active, Not Recruiting

NCT Number: NCT06477770

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Surgical Wound Infection Cesarean Wound; Dehiscence Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Clorhexidine soap

Procedure

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

Sucrose

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.

Other names: saccharose

Primary outcomes

  1. Changes of in-hospital days

    Time frame: from the first intervention to delayed primary closure (by third intention), on average less than 14 days

    from the intervention days

Secondary outcomes

  1. Change of Satisfaction scale for scar assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional Autonoma de Honduras

Other

Registry information

Official study title

Granulated Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time. Single-blind Randomized Clinical Trial

Acronym: SAGRA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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