Comparison of silver spray and betadine in wound healing and surgical wound infection rates

The effectiveness of silver spray compared to betadine (povidone iodine) on wound healing and surgical wound infection rates in patients with open fractures of the lower extremities

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251113067986N1

Enrollment

Registered

2025-12-17

Start date

2025-12-06

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical wounds in patients with open fractures of the lower limb bones. Open wound of lower limb, level unspecified

Interventions

Intervention 1: Intervention group: After the surgery, patients in this group will be dressed with a wound dressing with Silosept spray containing silver nanocolloid (100 ml, Cinagen Company). The sol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of open fracture and need for open surgery and internal fixation Hospitalization and the need for surgery and initial dressing No known hypersensitivity to silver or betadine Absence of underlying diseases (diabetes and BMI above 40) Completing the informed consent form

Exclusion criteria

Exclusion criteria: Patients who require amputation due to acute conditions Severe open fractures or requiring extensive tissue flap/graft The occurrence of complications unrelated to the study that make it impossible to continue the study (such as new strokes) Patient non-cooperation or withdrawal during follow-up and concomitant use of medications or methods that directly affect wound healing (such as long-term use of corticosteroids)

Design outcomes

Primary

Measure	Time frame
Surgical wound infection rate. Timepoint: Days 1, 3, 7, 11, 15 and 30 after surgery. Method of measurement: Clinical Signs and Symptoms Checklist and Wound Infection Assessment Checklist (UPPER/LOWER Checklist).	—

Secondary

Measure	Time frame
Length of hospital stay after surgery (days). Timepoint: At discharge. Method of measurement: Number of days of hospitalization from the day of surgery to the day of discharge.;The amount of antibiotic use. Timepoint: Up to 30 days after surgery. Method of measurement: Accurately record in the file: number of days of intravenous/oral antibiotic administration and calculate Defined Daily Dose according to World Health Organization.;Direct cost of care Wound care and infection treatment. Timepoint: Up to 30 days after surgery. Method of measurement: Total costs of dressings, topical and systemic medications, debridement, testing, radiography, readmission, and visit fees based on hospital invoices or Ministry of Health fees.	—

Measure

Time frame

Length of hospital stay after surgery (days). Timepoint: At discharge. Method of measurement: Number of days of hospitalization from the day of surgery to the day of discharge.;The amount of antibiotic use. Timepoint: Up to 30 days after surgery. Method of measurement: Accurately record in the file: number of days of intravenous/oral antibiotic administration and calculate Defined Daily Dose according to World Health Organization.;Direct cost of care Wound care and infection treatment. Timepoint: Up to 30 days after surgery. Method of measurement: Total costs of dressings, topical and systemic medications, debridement, testing, radiography, readmission, and visit fees based on hospital invoices or Ministry of Health fees.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Hashem Taghi

Mazandaran University of Medical Sciences

m.hashemtaghi@mazums.ac.ir+98 919 882 4118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026