Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247897
Status:
COMPLETED
Last Update Posted:
2011-04-12
First Post:
2005-11-01
Brief Title:
Comparing Skin Disinfectants Before Labour Epidural Analgesia
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
What is the Best Skin Preparation Solution for Labour Epidural Analgesia A Randomized Prospective Trial Comparing ChloraprepTM DuraprepTM and Chlorhexidine 05 in 70 Alcohol
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Womens Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada PHAC prior to placing special intravenous lines There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective
Detailed Description:
Bacterial colonization of epidural catheters is known to occur and it has been suggested that catheter contamination occurs more frequently in the obstetric setting Epidural catheters are usually colonized by the flora present at the skin insertion site and the rate of colonization varies from 5 to 30 At present there is a lack of scientific information available in order to make an evidence-based decision about skin disinfection prior to epidural analgesia The labouring woman appears to have higher risk for infectious complications of epidural analgesia than other surgical patients
All parturients considering a labour epidural who are admitted to Labour and Delivery at BC Womens Hospital during daytime weekday hours will be given an information sheet on the study by the Assessment room nurse The Labour and Delivery Room nurses which includes the Assessment room are generally the first healthcare providers with whom women discuss labour epidural analgesia once admitted to hospital All women interested in labour epidural analgesia who are admitted to Labour and Delivery either via the Assessment room or from one of the inpatient wards will be provided with the study information After adequate time has been given for consideration of the study information one of the researchers who is not directly involved in the patients care will approach the patient for consent to participate in the study This will happen prior to the actual request for labour epidural analgesia therefore avoiding the point of pain at which the woman requires a labour epidural Written consent will be obtained at that time Upon request for a labour epidural the woman will be randomized into one of 3 groups via a computer-generated randomization table ZRandom Group C will be ChloraprepTM Group D DuraprepTM and Group S chlorhexidine 05 in 70 alcohol
Exclusion criteria include temperature 38oC orally at time of epidural request local skin or generalized infection systemic antibiotics administered prior to epidural request presence of ruptured membranes 24 hours combined spinal-epidural analgesia planned unable to speakunderstand English allergy to chlorhexidine or iodine and patient refusal
The attending anesthesiologist will wear a clean mask clean hisher hands with either a wet scrub or alcohol-based antiseptic and don sterile procedure gloves Patients will be placed in either the left lateral or sitting position according to anesthesiologists preference The skin overlying the lumbar interspaces will then be cleansed with the antiseptic solution according to the recommended protocol for each solution
Specific instructions for skin disinfection will be provided in an envelope to the attending anesthesiologist according to the randomization group
1 Subjects in the S group will have three applications of chlorhexidine 05 in 70 alcohol applied according to standard protocol The chlorhexidine will be poured from a multi-use bottle into the sterile tray provided in the epidural kit Sterile prep sponge sticks are part of the tray Each sponge stick will be saturated with chlorhexidine and a 15 cm square area will be prepared over the L1-L5 interspaces using the centre-out method allowing time for the solution to air-dry prior to proceeding
2 Subjects in the D group will have their skin prepared with a single-use 6mL-unit applicator that contains a sterile crushable ampoule of iodine 07 with 74 isopropyl alcohol The solution is allowed to flow into the sponge tip via gravity and pumping action on the handle following activation of the applicator lever A 15 cm square area over the L1-L5 interspaces will be covered using the centre-out method with a single application and the solution will be allowed to air dry prior to proceeding
3 Subjects in the C group will have their skin prepared with a single-use 105 mL-unit applicator that contains a sterile crushable ampoule of chlorhexidine gluconate 2 with isopropyl alcohol 70 Following crushing the ampule with the outer wings of the sponge applicator the solution will be pumped into the sponge tip until wet A 15 cm square area over the L1-5 interspaces will be covered using the centre-out method with a single application The solution will be allowed to air-dry prior to proceeding
Epidurals will be placed between the L3 and L5 interspaces using a 17 gauge Tuohy needle by loss of resistance to air or saline depending on operator choice A 19 gauge Arrow flex tip endhole epidural catheter will be advanced to a depth of 4 to 6 cm within the epidural space The catheter will be fixed in place by a sterile semi-permeable dressing Tegaderm TM and the proximal part of the catheter will be connected to a 02 micrometre filter Standardized solutions of bupivacaine 008 or 0125 with fentanyl 2 microgramsmL prepared aseptically by the hospital pharmacy will be used via the PCEA technique Any initiation bolus manual top-up or top-up for surgical anesthesia will be prepared aseptically by the attending anesthesiologist as needed and injected into the epidural catheter through the filter
There are no identifiable risks beyond potential reaction to the skin disinfectant All of the skin preparation solutions are approved for skin disinfection prior to invasivesurgical procedures There is no published data on the incidence of reaction to any of these products and nothing that indicates one solution may have more inherent risk than the others
Cultures and Microbiology
All skin culture samples will be taken by one of the researchers All skin cultures will be obtained using sterile culture swabs Copan Venturi Transport system pre-moistened in sterile normal saline taken from a 5 cm square area of skin A baseline culture of skin flora at the proposed epidural insertion site will be taken prior to epidural insertion The second culture will be taken immediately following skin antisepsis but before epidural insertion to determine the initial efficacy of the antiseptic solution The third culture will be taken following removal of the sterile occlusive dressing immediately prior to epidural catheter removal Prior to obtaining the epidural catheter tip for culture the area of skin around the epidural catheter is disinfected with isopropyl alcohol This is done to reduce the risk of skin contamination of the epidural catheter tip Ten seconds later the epidural catheter is removed by a researcher wearing a mask and sterile gloves using sterile forceps and the distal 3-4 cm is transacted with a sterile scissors
The swabs will be coded placed into 10 ml thioglycolate broth BBL Becton-Dickinson and hand-delivered to the Microbiology lab at BC Childrens and Womens Hospital The tubes will then be spun for 1 minute to suspend organisms Each swab and 01 ml aliquot of the suspension will then be inoculated onto blood agar plates The epidural catheter tips will be placed in plain CS containers and hand-delivered to the Microbiology lab where they will be rolled over blood agar plates Standard culture techniques for the skin swabs and epidural catheter tips will be employed to semi-quantitatively determine the bacterial count colony-forming units or CFUs and identify the micro-organisms The CDC and PHAC definition for bacterial colonization of intravascular devices is a growth of 15 or more colony forming unitsml We plan to use this as our definition for colonization of epidural catheters
All parturients considering a labour epidural who are admitted to Labour and Delivery at BC Womens Hospital during daytime weekday hours will be given an information sheet on the study by the Assessment room nurse The Labour and Delivery Room nurses which includes the Assessment room are generally the first healthcare providers with whom women discuss labour epidural analgesia once admitted to hospital All women interested in labour epidural analgesia who are admitted to Labour and Delivery either via the Assessment room or from one of the inpatient wards will be provided with the study information After adequate time has been given for consideration of the study information one of the researchers who is not directly involved in the patients care will approach the patient for consent to participate in the study This will happen prior to the actual request for labour epidural analgesia therefore avoiding the point of pain at which the woman requires a labour epidural Written consent will be obtained at that time Upon request for a labour epidural the woman will be randomized into one of 3 groups via a computer-generated randomization table ZRandom Group C will be ChloraprepTM Group D DuraprepTM and Group S chlorhexidine 05 in 70 alcohol
Exclusion criteria include temperature 38oC orally at time of epidural request local skin or generalized infection systemic antibiotics administered prior to epidural request presence of ruptured membranes 24 hours combined spinal-epidural analgesia planned unable to speakunderstand English allergy to chlorhexidine or iodine and patient refusal
The attending anesthesiologist will wear a clean mask clean hisher hands with either a wet scrub or alcohol-based antiseptic and don sterile procedure gloves Patients will be placed in either the left lateral or sitting position according to anesthesiologists preference The skin overlying the lumbar interspaces will then be cleansed with the antiseptic solution according to the recommended protocol for each solution
Specific instructions for skin disinfection will be provided in an envelope to the attending anesthesiologist according to the randomization group
1 Subjects in the S group will have three applications of chlorhexidine 05 in 70 alcohol applied according to standard protocol The chlorhexidine will be poured from a multi-use bottle into the sterile tray provided in the epidural kit Sterile prep sponge sticks are part of the tray Each sponge stick will be saturated with chlorhexidine and a 15 cm square area will be prepared over the L1-L5 interspaces using the centre-out method allowing time for the solution to air-dry prior to proceeding
2 Subjects in the D group will have their skin prepared with a single-use 6mL-unit applicator that contains a sterile crushable ampoule of iodine 07 with 74 isopropyl alcohol The solution is allowed to flow into the sponge tip via gravity and pumping action on the handle following activation of the applicator lever A 15 cm square area over the L1-L5 interspaces will be covered using the centre-out method with a single application and the solution will be allowed to air dry prior to proceeding
3 Subjects in the C group will have their skin prepared with a single-use 105 mL-unit applicator that contains a sterile crushable ampoule of chlorhexidine gluconate 2 with isopropyl alcohol 70 Following crushing the ampule with the outer wings of the sponge applicator the solution will be pumped into the sponge tip until wet A 15 cm square area over the L1-5 interspaces will be covered using the centre-out method with a single application The solution will be allowed to air-dry prior to proceeding
Epidurals will be placed between the L3 and L5 interspaces using a 17 gauge Tuohy needle by loss of resistance to air or saline depending on operator choice A 19 gauge Arrow flex tip endhole epidural catheter will be advanced to a depth of 4 to 6 cm within the epidural space The catheter will be fixed in place by a sterile semi-permeable dressing Tegaderm TM and the proximal part of the catheter will be connected to a 02 micrometre filter Standardized solutions of bupivacaine 008 or 0125 with fentanyl 2 microgramsmL prepared aseptically by the hospital pharmacy will be used via the PCEA technique Any initiation bolus manual top-up or top-up for surgical anesthesia will be prepared aseptically by the attending anesthesiologist as needed and injected into the epidural catheter through the filter
There are no identifiable risks beyond potential reaction to the skin disinfectant All of the skin preparation solutions are approved for skin disinfection prior to invasivesurgical procedures There is no published data on the incidence of reaction to any of these products and nothing that indicates one solution may have more inherent risk than the others
Cultures and Microbiology
All skin culture samples will be taken by one of the researchers All skin cultures will be obtained using sterile culture swabs Copan Venturi Transport system pre-moistened in sterile normal saline taken from a 5 cm square area of skin A baseline culture of skin flora at the proposed epidural insertion site will be taken prior to epidural insertion The second culture will be taken immediately following skin antisepsis but before epidural insertion to determine the initial efficacy of the antiseptic solution The third culture will be taken following removal of the sterile occlusive dressing immediately prior to epidural catheter removal Prior to obtaining the epidural catheter tip for culture the area of skin around the epidural catheter is disinfected with isopropyl alcohol This is done to reduce the risk of skin contamination of the epidural catheter tip Ten seconds later the epidural catheter is removed by a researcher wearing a mask and sterile gloves using sterile forceps and the distal 3-4 cm is transacted with a sterile scissors
The swabs will be coded placed into 10 ml thioglycolate broth BBL Becton-Dickinson and hand-delivered to the Microbiology lab at BC Childrens and Womens Hospital The tubes will then be spun for 1 minute to suspend organisms Each swab and 01 ml aliquot of the suspension will then be inoculated onto blood agar plates The epidural catheter tips will be placed in plain CS containers and hand-delivered to the Microbiology lab where they will be rolled over blood agar plates Standard culture techniques for the skin swabs and epidural catheter tips will be employed to semi-quantitatively determine the bacterial count colony-forming units or CFUs and identify the micro-organisms The CDC and PHAC definition for bacterial colonization of intravascular devices is a growth of 15 or more colony forming unitsml We plan to use this as our definition for colonization of epidural catheters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None