Trial Outcomes & Findings for Topical Antibiotic Prophylaxis for Eyelids (NCT NCT03199911)
NCT ID: NCT03199911
Last Updated: 2020-07-21
Results Overview
The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
401 participants
Primary outcome timeframe
First Post-Operative Visit (~7-14 days)
Results posted on
2020-07-21
Participant Flow
Participant milestones
| Measure |
Topical Antibiotic Ointment
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Overall Study
STARTED
|
208
|
193
|
|
Overall Study
Did Not Proceed With Surgery
|
2
|
1
|
|
Overall Study
Received Allocated Treatment
|
206
|
192
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Primary Outcome Analyzed
|
201
|
187
|
|
Overall Study
COMPLETED
|
201
|
187
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Topical Antibiotic Ointment
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Did not proceed with surgery
|
2
|
1
|
Baseline Characteristics
Topical Antibiotic Prophylaxis for Eyelids
Baseline characteristics by cohort
| Measure |
Topical Antibiotic Ointment
n=206 Participants
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
n=192 Participants
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 16.7 • n=93 Participants
|
63.4 years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
63.5 years
STANDARD_DEVIATION 16.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
239 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=93 Participants
|
179 Participants
n=4 Participants
|
368 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Smoking status
Yes
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Smoking status
No
|
188 Participants
n=93 Participants
|
178 Participants
n=4 Participants
|
366 Participants
n=27 Participants
|
|
Smoking status
Unknown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
High risk for infection
Yes
|
44 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
High risk for infection
No
|
162 Participants
n=93 Participants
|
145 Participants
n=4 Participants
|
307 Participants
n=27 Participants
|
|
Asplenia
Yes
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Asplenia
No
|
205 Participants
n=93 Participants
|
192 Participants
n=4 Participants
|
397 Participants
n=27 Participants
|
|
Autoimmune disease
Yes
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Autoimmune disease
No
|
200 Participants
n=93 Participants
|
190 Participants
n=4 Participants
|
390 Participants
n=27 Participants
|
|
Diabetes mellitus
Yes
|
24 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Diabetes mellitus
No
|
182 Participants
n=93 Participants
|
161 Participants
n=4 Participants
|
343 Participants
n=27 Participants
|
|
Human immunodeficiency virus infection
Yes
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Human immunodeficiency virus infection
No
|
206 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
394 Participants
n=27 Participants
|
|
Malignancy
Yes
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Malignancy
No
|
206 Participants
n=93 Participants
|
190 Participants
n=4 Participants
|
396 Participants
n=27 Participants
|
|
Organ transplantation
Yes
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Organ transplantation
No
|
206 Participants
n=93 Participants
|
191 Participants
n=4 Participants
|
397 Participants
n=27 Participants
|
|
Blepharoplasty
Yes
|
48 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Blepharoplasty
No
|
158 Participants
n=93 Participants
|
153 Participants
n=4 Participants
|
311 Participants
n=27 Participants
|
|
Browplasty
Yes
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Browplasty
No
|
203 Participants
n=93 Participants
|
192 Participants
n=4 Participants
|
395 Participants
n=27 Participants
|
|
Dacryocystorhinostomy
Yes
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Dacryocystorhinostomy
No
|
205 Participants
n=93 Participants
|
186 Participants
n=4 Participants
|
391 Participants
n=27 Participants
|
|
Ectropion/Entropion repair
Yes
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Ectropion/Entropion repair
No
|
181 Participants
n=93 Participants
|
167 Participants
n=4 Participants
|
348 Participants
n=27 Participants
|
|
Eyelid lesion removal and/or biopsy
Yes
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Eyelid lesion removal and/or biopsy
No
|
170 Participants
n=93 Participants
|
156 Participants
n=4 Participants
|
326 Participants
n=27 Participants
|
|
Ptosis repair
Yes
|
41 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Ptosis repair
No
|
165 Participants
n=93 Participants
|
149 Participants
n=4 Participants
|
314 Participants
n=27 Participants
|
|
Reconstruction after Mohs surgery
Yes
|
25 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Reconstruction after Mohs surgery
No
|
181 Participants
n=93 Participants
|
170 Participants
n=4 Participants
|
351 Participants
n=27 Participants
|
|
Orbitotomy
Yes
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Orbitotomy
No
|
198 Participants
n=93 Participants
|
181 Participants
n=4 Participants
|
379 Participants
n=27 Participants
|
|
Tarsorrhaphy
Yes
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Tarsorrhaphy
No
|
203 Participants
n=93 Participants
|
191 Participants
n=4 Participants
|
394 Participants
n=27 Participants
|
|
Wedge excision
Yes
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Wedge excision
No
|
191 Participants
n=93 Participants
|
177 Participants
n=4 Participants
|
368 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: First Post-Operative Visit (~7-14 days)The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.
Outcome measures
| Measure |
Topical Antibiotic Ointment
n=201 Participants
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
n=187 Participants
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Number of Participants With Surgical Site Infections
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: First Post-Operative Visit (~7-14 days)A secondary outcome is the rate of superficial or deep SSI in participants considered high risk for infection due to comorbidities such as smoking, exogenous immunosuppressive agent use, or medical conditions causing immunosuppression such as diabetes mellitus.
Outcome measures
| Measure |
Topical Antibiotic Ointment
n=44 Participants
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
n=47 Participants
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Number of High Risk Participants With Surgical Site Infections
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: First Post-Operative Visit (~7-14 days)A secondary outcome recording the rate of wound dehiscence after surgery.
Outcome measures
| Measure |
Topical Antibiotic Ointment
n=201 Participants
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
n=187 Participants
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Number of Participants With Wound Dehiscence
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: First Post-Operative Visit (~7-14 days)A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.
Outcome measures
| Measure |
Topical Antibiotic Ointment
n=201 Participants
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
n=187 Participants
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Number of Participants With Allergic Contact Dermatitis
|
1 Participants
|
1 Participants
|
Adverse Events
Topical Antibiotic Ointment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Topical Non-Antibiotic Ointment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topical Antibiotic Ointment
n=208 participants at risk
The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
|
Topical Non-Antibiotic Ointment
n=193 participants at risk
The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic contact dermatitis
|
0.50%
1/201 • Number of events 1 • Adverse events were collected until the final post-operative visit (approximately 3 months).
Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.
|
0.53%
1/187 • Number of events 1 • Adverse events were collected until the final post-operative visit (approximately 3 months).
Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence
|
3.5%
7/201 • Number of events 7 • Adverse events were collected until the final post-operative visit (approximately 3 months).
Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.
|
2.7%
5/187 • Number of events 5 • Adverse events were collected until the final post-operative visit (approximately 3 months).
Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.
|
Additional Information
Davin Ashraf MD
University of California, San Francisco
Phone: 415-353-2800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place