Paranasal Sinus Disease
Conditions
Brief summary
This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.
Detailed description
Same as above
Interventions
DRUGBacitracin
Bacitracin soaked nasopore sponge
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.
Exclusion criteria
* Age less then 18 * Known sensitivity to Bacitracin * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Infection | 90 days | Number of participants without infections on post-op visits 90 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bacitracin Nasopore sponge soaked in Bacitracin
Bacitracin: Bacitracin soaked sponge | 113 |
| Saline Nasopore sponge soaked in saline | 113 |
| Total | 226 |
Baseline characteristics
| Characteristic | Saline | Total | Bacitracin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 226 Participants | 113 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 113 participants | 226 participants | 113 participants |
| Sex: Female, Male Female | 49 Participants | 98 Participants | 49 Participants |
| Sex: Female, Male Male | 64 Participants | 128 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 113 |
| other Total, other adverse events | 0 / 113 | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 | 0 / 113 |
Outcome results
Primary
Rate of Infection
Number of participants without infections on post-op visits 90 days.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bacitracin | Rate of Infection | 113 Participants |
| Saline | Rate of Infection | 113 Participants |