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

NCT06477770 | Active Not Recruiting DMC

• 1 other identifier: PGO-UNAH-47-2-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection; Cesarean Wound; Dehiscence

Outcome Measures

Primary Outcomes (1)

• Changes of in-hospital days

  from the intervention days

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

Secondary Outcomes (1)

• Change of Satisfaction scale for scar assessment

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Procedure: Clorhexidine soap; Other: Sucrose

Control

SHAM COMPARATOR

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

Procedure: Clorhexidine soap

Interventions

Clorhexidine soap PROCEDURE

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

Control; Intervention

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.

Also known as: saccharose

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: puerperium
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• 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.

  PMID: 32496977 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sucrose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, research coordinator of the postgraduate course in gynecology and obstetrics

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 27, 2024
• Study Start: June 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months
• Access Criteria: e mail

Locations

HO (1)