Betadine Versus Saline in Swapping of Subcutaneous Tissue

NCT06595823 | Completed DMC

• 1 other identifier: Asmaa Gamal Mohamed
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported. The risk of maternal morbidity and mortality is higher in caesarean section than in vaginal birth; postoperative infection is a common component of morbidity. With the increase in caesarean section, it is important that the risks to the mother are minimized as far as possible. Women who give birth by caesarean section are exposed to both endogenous (internal) and exogenous (external) sources of infection during birth. Exposure to a hospital environment places these women at risk of developing hospital-acquired infections. The rate of post-caesarean infection has been estimated to be 10 times greater than that after vaginal birth.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Treatment of surgical site infections

  Assessment of Number of Participants With Treatment of surgical site infections using Povidine Iodine or by using saline and which one is effective in Treatment

  6 weeks after cesarean section

Study Arms (3)

Group A (Povidone-Iodine10%)

ACTIVE COMPARATOR

About 100 patients women who underwent elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 10% solution.

Drug: Betadine

Group B (Saline0.9%)

ACTIVE COMPARATOR

About 100 patients women who underwent elective caesarian section with subcutaneous tissue irrigation with normal saline0.9%

Drug: Betadine

Group C (the control group)

PLACEBO COMPARATOR

About 100 patients women who underwent elective caesarian section without irrigation of the subcutaneous tissue with betadine or saline.

Drug: Betadine

Interventions

Betadine DRUG

To compare between Betadine (10%) and saline (0.9%) in swapping of subcutaneous tissue for prevention of surgical site infection after primary elective caesarian section.

Also known as: Saline

Group A (Povidone-Iodine10%); Group B (Saline0.9%); Group C (the control group)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary Elective Cs .
• Age: 20 - 35 years old,
• elective caesarean section time from skin incision to skin closure less than 60 minute,
• Body Mass Index: 20- 30 Kg/m2.

You may not qualify if:

• Diabetes mellitus,
• feverish patient,
• patient using steroids for chronic illness,
• prelabour rupture of membrane,
• difference in pre and postoperative hemoglobin more than 10%,
• Patients with coagulopathies,
• mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Sponsors & Collaborators

• Egymedicalpedia: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar University hospitals

Asyut, 71524, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Ahmed Abd El Hameed Ahmed, Professor

  Obstetrics and Gynecology Department, Faculty of medicine, Al-Azhar University, Assuit.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: March 10, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 10, 2023
• Last Updated: September 23, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)