Skin Infection
Conditions
Brief summary
Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing aid associated skin breakdown better than standard care of bacitracin ointment alone in adult patients.
Detailed description
This is a prospective study. Multiple surgeons will perform the bone anchored hearing aids (BAHI) implantation surgery. Patients will be randomized to either postoperative medicinal honey or postoperative standard care of bacitracin ointment alone using a random number generator. There will be a total of two patient groups. The type of BAHI device used, laterally and the surgical technique will be recorded. Treatment groups: Group 1-patients undergoing BAHI implantation who will be postoperatively treated with medicinal honey. Group 2- patients undergoing BAHI implantation who will be postoperatively treated with bacitracin ointment as standard care.
Interventions
DRUGMedicinal honey
Treat healing surgical site with medicinal honey
DRUGBacitracin
Treat healing surgical site with bacitracin
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing bone-anchored hearing aid implantation surgery.
Exclusion criteria
* patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op. | Postoperative wound healing was compared between two groups of patients, one group had medicinal honey applied at the BAHI abutment surgical site for the first 2 weeks postoperatively, while the other group had bacitracin applied for 2 weeks. The skin at the surgical site was photographed at each time point and the photographs randomized for evaluation. The appearance of the surgical site skin was graded based on Holgers Classification by 5 separate, blinded Otolaryngologists. Holgers Classification is graded Grade 0 to Grade 4 with Grade 4 having a worse outcome. Any skin breakdown will be graded based on the Holgers Classification: Grade 0 = no reaction; Grade 1 = reddish discoloration of the skin around the implant; Grade 2 = red and moist surface of the skin around the implant; Grade 3 = formation of granulation tissue around the implant; and Grade 4 = extensive soft-tissue reaction. Holgers score was not recorded before or the day of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Oral Antibiotics | Use of oral antibiotics during the 6 months follow-up was noted. | This was determined by whether or not the patient required oral antibiotics during the 6 month follow-up period. |
| Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op. | Patient's self-reported level of pain at the abutment site was provided based on the 0 to 10 Pain Scale with 0 being no pain at all, and 10 being the worst possible pain. Pain prior to surgery is not routinely assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bacitracin Standard care: BAHI abutment incision is coated in bacitracin. A healing cap is placed over the abutment and left for a week. The healing cap is removed on postoperative day 7. Patient is instructed to apply bacitracin ointment to the area for 2 weeks.
Bacitracin: Treat healing surgical site with bacitracin | 8 |
| Medicinal Honey Medicinal honey: Medicinal honey will be applied to the abutment site immediately after surgery. The healing cap will be placed on the BAHI site. The healing cap is removed on postoperative day 7. Patient is instructed to apply medicinal honey daily to the area for 2 weeks.
Medicinal honey: Treat healing surgical site with medicinal honey | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Bacitracin | Medicinal Honey | Total |
|---|---|---|---|
| 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 | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 13 Participants |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome)
Postoperative wound healing was compared between two groups of patients, one group had medicinal honey applied at the BAHI abutment surgical site for the first 2 weeks postoperatively, while the other group had bacitracin applied for 2 weeks. The skin at the surgical site was photographed at each time point and the photographs randomized for evaluation. The appearance of the surgical site skin was graded based on Holgers Classification by 5 separate, blinded Otolaryngologists. Holgers Classification is graded Grade 0 to Grade 4 with Grade 4 having a worse outcome. Any skin breakdown will be graded based on the Holgers Classification: Grade 0 = no reaction; Grade 1 = reddish discoloration of the skin around the implant; Grade 2 = red and moist surface of the skin around the implant; Grade 3 = formation of granulation tissue around the implant; and Grade 4 = extensive soft-tissue reaction. Holgers score was not recorded before or the day of surgery.
Time frame: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.
Population: Patients qualified for BAHI: single-sided deafness, conductive or mixed hearing loss on audiometric testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bacitracin | Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | 1 week | 1.06 Grade | Standard Deviation 0.78 |
| Bacitracin | Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | 3 months | 0.81 Grade | Standard Deviation 0.94 |
| Bacitracin | Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | 6 months | 1.25 Grade | Standard Deviation 1.08 |
| Medicinal Honey | Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | 1 week | 0.64 Grade | Standard Deviation 0.57 |
| Medicinal Honey | Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | 3 months | 0.50 Grade | Standard Deviation 0.56 |
| Medicinal Honey | Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | 6 months | 0.68 Grade | Standard Deviation 0.7 |
Secondary
Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain
Patient's self-reported level of pain at the abutment site was provided based on the 0 to 10 Pain Scale with 0 being no pain at all, and 10 being the worst possible pain. Pain prior to surgery is not routinely assessed.
Time frame: Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.
Population: The number of participants providing self-reported pain levels varied across time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bacitracin | Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | 1 week | 5.00 units on a scale | Standard Deviation 4.24 |
| Bacitracin | Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | 3 months | 7.33 units on a scale | Standard Deviation 2.08 |
| Bacitracin | Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | 6 months | 5.83 units on a scale | Standard Deviation 4.12 |
| Medicinal Honey | Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | 1 week | 2.00 units on a scale | Standard Deviation 2.65 |
| Medicinal Honey | Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | 3 months | 3.00 units on a scale | Standard Deviation 2.31 |
| Medicinal Honey | Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | 6 months | 0.58 units on a scale | Standard Deviation 1.02 |
Secondary
Number of Participants Requiring Oral Antibiotics
This was determined by whether or not the patient required oral antibiotics during the 6 month follow-up period.
Time frame: Use of oral antibiotics during the 6 months follow-up was noted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bacitracin | Number of Participants Requiring Oral Antibiotics | 4 Participants |
| Medicinal Honey | Number of Participants Requiring Oral Antibiotics | 0 Participants |