Decreasing Infection In Arthroscopic Shoulder Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | June 2017 |
| Contact: | Landon R Fine, DO |
| Email: | landonfine@gmail.com |
| Phone: | 3038849611 |
Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery
Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery
propionibacterium acne remains a leading cause of post-operative infections. The purpose of
this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to
chlorhexidine-impregnated skin preparation in attempting to lower the colonization
propionibacterium acne prior to surgery. This study will take cultures from patients who are
randomly assigned into groups that receive and do not receive benzoyl peroxide as additional
skin prep prior to elective shoulder surgery and compare quantified culture results.
propionibacterium acne remains a leading cause of post-operative infections. The purpose of
this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to
chlorhexidine-impregnated skin preparation in attempting to lower the colonization
propionibacterium acne prior to surgery. This study will take cultures from patients who are
randomly assigned into groups that receive and do not receive benzoyl peroxide as additional
skin prep prior to elective shoulder surgery and compare quantified culture results.
With IRB approval and informed consent to participate in the study, patients scheduled for
elective shoulder arthroscopy will be randomly selected and placed into 1 of 2 groups. Both
groups will adhere to the surgeon's preoperative protocol of showering the night before with
instructions to scrub the operative shoulder including the axilla with a chlorhexidine scrub
brush. Group 1 will be treated "per protocol" and only be given instructions to use
chlorhexidine. While group 2 will be provided a chlorhexidine scrub brush and a 1.5oz bottle
of 10% benzoyl peroxide emollient to be applied after using the chlorhexidine scrub. The
benzoyl peroxide should not be washed off prior to surgery.
Thirty minutes prior to incision, intravenous antibiotics, cefazolin or clindamycin if
penicillin intolerant, will be administered per protocol. Dry anaerobic culturettes will be
taken at the location of the expected posterior portal location before and after the
application of the chloraprep solution. At the time of surgery both groups will undergo
preoperative skin preparation, in sterile fashion, with our institutions "standard" protocol
utilizing ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El
Paso, Texas). In addition, a 3mm full thickness skin punch biopsy will be taken after,
application of chlorprep. Biopsies will be immediately placed, by the surgeon, in sterile
receptacle with sterile saline and sent to our microbiology department. The biopsy site will
be incorporated into the portal incision and will be closed appropriately minimizing the
morbidity of obtaining the biopsy.
The culture results will be recorded into a "dummy" account on McLaren's electronic medical
records program. This account ensures that the costs of the study are not charged to the
patient as well as blinding the patient and surgeon of the their results. The patient
correlating information will only be known to Dr. Fine and they will be kept in a password
protect computer document which will be kept in a off campus protected locked location.
The Microbiology lab will place the swab specimens in 1 ml of saline, vortex them, and
inoculate 0.01 mL onto an anaerobic blood agar plate. A chopped meat broth will also be
inoculated. The punch biopsies will be ground and then inoculated to an anaerobic blood agar
plate and a chopped meat broth. The anaerobic plates will be incubated in an anaerobic
chamber at 35°C. The plates and broth will be examined daily for the first 4 days, then on
days 7, 10 and 14 and any growth screened to determine if P. acnes is present. Results will
be reported as "no P. acnes isolated" or as "CFU/mL P. acnes" for the swab specimens. No
colony count can be issued for the biopsies. These will be reported semi-quantitatively as
rare, few, moderate or many. All plates will be read and counted manually by a laboratory
technician who is not involved in the study and has been blinded from preoperative prep
used. If any growth is detected, the sample will be considered positive.
elective shoulder arthroscopy will be randomly selected and placed into 1 of 2 groups. Both
groups will adhere to the surgeon's preoperative protocol of showering the night before with
instructions to scrub the operative shoulder including the axilla with a chlorhexidine scrub
brush. Group 1 will be treated "per protocol" and only be given instructions to use
chlorhexidine. While group 2 will be provided a chlorhexidine scrub brush and a 1.5oz bottle
of 10% benzoyl peroxide emollient to be applied after using the chlorhexidine scrub. The
benzoyl peroxide should not be washed off prior to surgery.
Thirty minutes prior to incision, intravenous antibiotics, cefazolin or clindamycin if
penicillin intolerant, will be administered per protocol. Dry anaerobic culturettes will be
taken at the location of the expected posterior portal location before and after the
application of the chloraprep solution. At the time of surgery both groups will undergo
preoperative skin preparation, in sterile fashion, with our institutions "standard" protocol
utilizing ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El
Paso, Texas). In addition, a 3mm full thickness skin punch biopsy will be taken after,
application of chlorprep. Biopsies will be immediately placed, by the surgeon, in sterile
receptacle with sterile saline and sent to our microbiology department. The biopsy site will
be incorporated into the portal incision and will be closed appropriately minimizing the
morbidity of obtaining the biopsy.
The culture results will be recorded into a "dummy" account on McLaren's electronic medical
records program. This account ensures that the costs of the study are not charged to the
patient as well as blinding the patient and surgeon of the their results. The patient
correlating information will only be known to Dr. Fine and they will be kept in a password
protect computer document which will be kept in a off campus protected locked location.
The Microbiology lab will place the swab specimens in 1 ml of saline, vortex them, and
inoculate 0.01 mL onto an anaerobic blood agar plate. A chopped meat broth will also be
inoculated. The punch biopsies will be ground and then inoculated to an anaerobic blood agar
plate and a chopped meat broth. The anaerobic plates will be incubated in an anaerobic
chamber at 35°C. The plates and broth will be examined daily for the first 4 days, then on
days 7, 10 and 14 and any growth screened to determine if P. acnes is present. Results will
be reported as "no P. acnes isolated" or as "
colony count can be issued for the biopsies. These will be reported semi-quantitatively as
rare, few, moderate or many. All plates will be read and counted manually by a laboratory
technician who is not involved in the study and has been blinded from preoperative prep
used. If any growth is detected, the sample will be considered positive.
Inclusion criteria:
1. Elective arthroscopic shoulder surgery
2. Ages > 18
3. Male and Female
Exclusion criteria:
1. Active Infection
2. History of ipsilateral prior shoulder surgery
3. History of prior shoulder infection
4. Current use of Antibiotics
5. History of immunosuppression
6. Open wounds
7. History of Inflammatory arthritis
8. Allergy to benzoyl peroxide
9. Allergy to chlorhexidine
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