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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clorhexidine soap | Procedure | surgical wound will be washed with saline solution and 10 ml of chlorhexidine soap |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
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puerperium
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo A. Gutierrez Ramirez, MD, MSc | Universidad Nacional Autonoma de Honduras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Escuela | Tegucigalpa | Francisco Morazán Department | 11101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32496977 | Background | 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. |
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all IPD that underlie results in a publication
12 months
e mail
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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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.
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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.
| 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. |
|
|
| 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000073893 |
| Sugars |