Surgical Wound InfectionSAGRANCT06477770
Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time
A study testing Clorhexidine soap and Sucrose in people with Surgical Wound Infection and Cesarean Wound; Dehiscence, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Infection, Cesarean Wound; Dehiscence
- What is being tested?
- Clorhexidine soap and Sucrose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteHonduras
- Study dates
- 1 Jun 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Granulated Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time. Single-blind Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Clorhexidine soap, Sucrose
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clorhexidine soapProcedure or surgery
surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap
SucroseOther
Also called saccharose
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Clorhexidine soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of in-hospital days
from the intervention days
Measured: 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
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jun 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc, Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477770
- Sponsor's protocol ID
- PGO-UNAH-47-2-2024
- Acronym
- SAGRA
- Status last verified
- Aug 2024
- First submitted
- 19 Jun 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 32496977
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulated Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time. Single-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06477770
- Acronym / sponsor ID
- SAGRA / PGO-UNAH-47-2-2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Clorhexidine soap, Other: SucroseThe 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 | Sham comparator | Procedure: Clorhexidine soapThe surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap, once a day, and then covered with sterile gauze. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clorhexidine soapsurgical wound will be washed with saline solution and 10 ml of chlorhexidine soap | Procedure or surgery | Control, Intervention |
| SucroseAlso: saccharose75 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 | Intervention |
Primary outcome
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
1 secondary outcome
Change of Satisfaction scale for scar assessment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 32496977Li 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A. Gutierrez Ramirez, MD, MSc study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clorhexidine soap and Sucrose in people with Surgical Wound Infection and Cesarean Wound; Dehiscence, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of in-hospital days (time frame: from the first intervention to delayed primary closure (by third intention), on average less than 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06477770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.