Surgical Site Skin Preparation within the Perioperative Environment

Publication: 01/04/2019

Next review: 22/03/2025

Clinical Guideline

CURRENT

ID: 5949

Approved By: Trust Clinical Guidelines Group

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Please check the patients allergy status, as they may be allergic to Chlorhexidine, and alternative ( Providine iodine) solution will be required.
Be aware: Chlorhexidine is considered an environmental allergen.
Refer to the asepsis guidance.

Surgical Site Skin Preparation within the Perioperative Environment

Definitions
Summary of Guideline
Aims
Background
Allergies
Selection and Use of Surgical Skin Preparation Solutions
Escalation
Appendix 1 Properties of active agents in pre-operative skin preparations
Appendix 2 SURGICAL SITE – skin prep area dependent on surgical/ invasive procedure
Appendix 3 Skin Preparation solutions
Appendix 4 Joint RCS/MHRA Statement on use of Topical Chlorhexidine for Skin Preparation Prior to Surgery (2015)
Appendix 5 Surgical Skin Preparation Audit - Auditor to observe

Definitions

Competent Practitioner	A Practitioner working in the Operating Theatres, who has completed their dual role competencies for Skin Preparation and Draping,
Dual Role	When a Perioperative Scrub Practitioner acting as the scrubbed person, intermittently during the operative procedure, acts as an assistant to the Operating Clinician, working within defined criteria.
Operating Clinician	Surgeon/ Practitioner performing the surgery.
Medical Assistant	A doctor acting as an assistant for a surgical procedure.
Surgical Care Practitioner (SCP)	A registered healthcare professional (nurse, ODP or other allied health professional) who has extended the scope of their practice to work as a member of a surgical team performing surgical intervention, preoperative & postoperative care under the supervision of the Consultant Surgeon.
Surgical First Assistant/ Advanced Scrub Practitioner (SFA/ASP)	A registered Nurse or Operating Department Practitioner who provides continuous competent and dedicated assistance under the direct supervision of the operating surgeon throughout the procedure, whilst not performing any form of surgical intervention (PCC 2018).check for latest version

Summary of Guideline

This guideline aims to support the appropriate selection and use of skin preparation solutions for patients undergoing surgical procedures.

Aims

To improve the selection and use of skin preparation solutions within the perioperative environment.
To reduce resident and transient microbial counts at the surgical site immediately prior to surgical incision.
To aid reduction of surgical site infections.
To prevent harm caused by incorrect selection of surgical skin preparation solution.

Background

Surgical Site Skin Preparation refers to the preoperative treatment of skin. This does not only refer to the surgical site but a larger region surrounding the incision site to allow access. The aim of the skin preparation process is to reduce the microbial load on the skin before a surgical incision or invasive procedure is undertaken.

Allergies

The allergy status of the patient must be checked prior to skin preparation including any known allergies to Chlorhexidine, Iodine or other products. All available reference sources must be checked i.e. eMeds, ppm+ and paper records

Selection and Use of Surgical Skin Preparation Solutions

Prior to Skin Prepping
Skin preparation must only happen following a ‘time out’, completed as part of the WHO Safer Procedure Checklist. Further guidance on this can be found on the trust intranet:
The competent practitioner responsible for carrying out skin preparation must ensure the area to be prepped is clear from gross contamination. If necessary the skin should be washed prior to prepping with a soap solution. This should be well rinsed prior to surgical skin preparation. Organic matter can inhibit the effectiveness of the antiseptic solutions used for skin prep.
Contaminated areas close to, but not included in the exposure once the drapes are in place, should be isolated e.g. stomas should be sealed off with a sterile adhesive drape.

Only operating clinicians, medical assistants, surgical care practitioners, surgical first assistants or scrub practitioners deemed as competent may undertake surgical skin preparation. Scrub practitioners must complete the relevant Dual Role Competency in order to be deemed competent. Assessable via Leeds Health Pathways:

The whole team must protect the patient’s dignity both prior to and during skin preparation, only uncovering the necessary area immediately prior to preparation.

Hair should only be removed if absolutely required. It should be done as close to the time of surgery as possible. The only recommended method is by electric/ battery operated clippers (NICE 2019)

Surgical site markings must remain visible after the skin preparation and application of theatre drapes. More information about this can be accessed via the WHO Safer Procedure Checklist and Surgical Site Marking SOP

Prep solution used must be documented in the patient records

General Considerations
Skin preparation must be carried out as close as possible to commencement of the procedure with an antiseptic solution.

There are two main antiseptic agents used for skin preparation:

Chlorhexidine gluconate (CHG), see Appendix 4
Iodophors (povidone iodine; PI)

They are available in either an aqueous or alcohol-based form. There is limited evidence to suggest that one agent is better than another.
The antiseptic used should have a broad spectrum of activity. The antiseptic solution is applied with a painting motion along with a gentle rubbing action to aid mechanical removal of microbes, chemical killing action with persistent biocidal properties which inhibit new growth of microorganisms on the skin. Friction has been shown to increase the antibacterial effect of an antiseptic (WHO 2009). Assessment of the state of the skin must be made and a clinical judgement made of the degree of friction possible to avoid damage. Skin preparation solutions must be allowed to dry before the drapes are fixed in place and an incision is made, which will allow sufficient time for the antiseptic to destroy the microorganisms on the skin.

NICE (2019) update of clinical guideline 74, shows evidence indicating a beneficial effect of Chlorhexidine over povidone-iodine but it was thought the evidence was insufficient to change the guidance choice of antiseptic solution

Staff members preparing patients skin must be aware of the flammability characteristics of the antiseptic alcohol solutions used in their specialty. Alcohol can cause burns by direct application of diathermy to the liquid alcohol solution or through an accumulation of alcohol fumes collecting under the surgical drapes which can then catch fire. Therefore it is essential to ensure all skin prep solutions are allowed to dry by evaporation.
Care must be taken to prevent pooling beneath the patient, in skin creases, under tourniquets, under diathermy return plates and near ECG or other electrodes.

Skin antiseptic may be confused with medication if both are placed in unlabelled gallipots on the sterile field. Therefore skin antiseptics should be removed from the sterile field immediately after use and medications must always be drawn directly from source ampoule or bottle using a closed system method.

How to select appropriate antiseptics?
Alcohol-based solutions should be used where they are suitable for the particular site of incision as they include an additional, rapid acting antiseptic agent that dries quickly. Alcohol can however cause damage to mucous membranes and aqueous solutions should be used for this type of surgery. The skin of pre-term infants is immature and exposure to antiseptics should be carefully considered as it may cause skin irritation, blistering or be absorbed.

Expert guidance supports the use of alcohol-based skin preparation solution where possible (Appendix one). Selection of CHG or PI depends on the patient, the site of incision and nature of procedure and should therefore be guided by local policy (Appendix 2).

Children and neonates

Special consideration should be taken with choice of skin prep solution in children and neonates. Evidence is lacking re the use of antiseptic solutions in both neonates and pre term infants as shown in a review by S Sathiyamurthy, J Banerjee et al, (2016).
Antiseptic use in the neonatal intensive care unit - a dilemma in clinical practice: An evidence based review (2016) (Accessed March 2022)

NICE guidelines for the prevention and Treatment of Surgical Site infections (2019, last updated 2020) covers preventing and treating surgical site infections in adults, young people and children who are having a surgical procedure involving a cut through the skin. These recommendations include preparation of the skin at the surgical site immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidone-iodine or chlorhexidine being most suitable.

First choice unless contraindicated or the surgical site is next to a mucous membrane	Alcohol-based solution of chlorhexidine At the time of publication (April 2019), 0.5% chlorhexidine in 70% alcohol solution (Hydrex; Prevase) was licensed for 'preoperative skin disinfection prior to minor surgical procedures' and 2.0% chlorhexidine in 70% alcohol applicators (ChloraPrep) was licensed for 'disinfection of the skin prior to invasive medical procedures'. Some formulations of chlorhexidine in alcohol were off label for this use. See NICE's information on prescribing medicines.
Alternative if the surgical site is next to a mucous membrane	Aqueous solution of chlorhexidine At the time of publication (April 2019), 4.0% aqueous chlorhexidine (Hibiscrub) was licensed for 'preoperative and postoperative skin antisepsis for patients undergoing elective surgery'; however, relevant instructions were limited to use as a body wash to be used before the person enters the operating theatre. Other formulations of aqueous chlorhexidine were off label for this use. See NICE's information on prescribing medicines.
Alternative if chlorhexidine is contraindicated	Alcohol-based solution of povidone-iodine At the time of publication (April 2019), 10% povidone-iodine alcoholic solution (Videne alcoholic tincture) was licensed for 'topical application'. 10% povidone-iodine (Betadine Alcoholic solution) was licensed for 'antiseptic skin cleanser for major and minor surgical procedures'. Other formulations of povidone-iodine alcoholic solution were off label for this use. See NICE's information on prescribing medicines.
If both an alcohol-based solution and chlorhexidine are unsuitable	Aqueous solution of povidone-iodine At the time of publication (April 2019), 7.5% povidone-iodine surgical scrub solution (Videne) was licensed for disinfecting the site of incision prior to elective surgery' and 7.5% povidone-iodine (Betadine surgical scrub) was licensed for 'preoperative preparation of patients' skin'. 10% iodine antiseptic solution (Videne) was licensed for 'disinfection of intact external skin or as a mucosal antiseptic' and 10% povidone-iodine solution (Standardised Betadine antiseptic solution) was licensed for 'preoperative and postoperative antiseptic skin cleanser for major and minor surgical procedures'. Other formulations of povidone-iodine aqueous solution were off label for this use. See NICE's information on prescribing medicines.

If the operating clinician favours the use of ChloraPrep applicators:
ChloraPrep® with Tint 2% Chlorhexidine gluconate /70% alcohol should only be used in children over 44 weeks gestational age for skin prepping appropriate areas ( see appendix 2)
ChloraPrep® without Tint 2% Chlorhexidine gluconate /70% alcohol may be used on all patients for skin prepping appropriate areas ( see appendix 2)
In babies less than 30 weeks gestational age a dabbing rather than rubbing technique should be employed to avoid skin irritation and excess absorption of the prepping solution.
Chloraprep (2% Chlorhexidine gluconate /70% alcohol) use as a skin prep in neonates and pre term babies is established practice within LTHT as shown in guidelines below:

Standard operating procedure for the insertion and maintenance of peripherally inserted central (PIC) lines in neonates

Suprapubic aspiration - Neonatal Unit SOP

Storage
Leeds Medicines Advisory Service, St James' University Hospital, Leeds Teaching Hospitals NHS Trust - Storage Instructions

Preparation name	Storage conditions	Expiry / disposal
Chloraprep	Flammable. This medicinal product does not require any special temperature storage conditions. Store in the original packaging; applicator is sterile unless seal is broken. Avoid exposure of the container and contents to naked flames during use, storage and disposal.	This product is for single use only. Any unused product or waste material should be discarded in accordance with local requirements. No additional environmental precautions for disposal are necessary.
Hydrex Pink	Do not store above 25°C. Store in the original package.	Nil information listed, use expiry date listed on product.
Hydrex Clear	Do not store above 25°C. Store in the original package.	Nil information listed, use expiry date listed on product.
Videne alcoholic	Do not store above 25°C. Store in the original package.	Nil information listed, use expiry date listed on product.
Videne antiseptic	Do not store above 25°C. Store in the original package. (see below additional information if warming the solution is required e.g. for neonates/children)	Nil information listed, use expiry date listed on product.
Warmed Videne antiseptic/ Betadine As supported by Leeds Medicines Advisory Service, St James' University Hospital, Leeds Teaching Hospitals NHS Trust	Stability data for Videne antiseptic shows no alteration to the product when stored at up to 40°C for 12 months. However, when the product is warmed this it is being used outside the product license. Another product (Betadine) has stability data for up to 6 months at 37.5°C.	Some standardisation of approach is helpful. Whilst using to the original expiry date isn't supported by the manufacturer's information, storage for up to 6 months at elevated temperatures would be supportable.
Unisept 0.05% STERETS Chlorhexidine Gluconate	Do not store the product above 25°C. Store the sachets in the outer container (plastic pouch).	Use expiry date listed on product.
0.1% Chlorhexidine Gluconate 1 in 1000 sterile solution As supplied by Huddersfield Pharmacy Specials (HPS)	The product is prepared by HPS as an unlicensed medicine by the dilution of Chlorhexidine gluconate 20% concentrated solution with Water for Injection and sterilised by moist heat at 121°C for 15 minutes. The product has been used for skin preparation (although more concentrated solutions are generally used) and bladder irrigation. This particular concentration is used by various hospitals.	Use expiry date listed on product. Storage should be in a locked cupboard away from direct sunlight or artificial light. Chlorhexidine solutions will darken on storage in the light and on ageing. The shelf life of the product is 2 years stored below 25°C, not refrigerated, protected from light. Once opened: Discard remaining solution after procedure. Chlorhexidine solutions are very toxic to aquatic life with long lasting effects. Avoid release to the environment. Collect spillages. Dispose of the contents as pharmaceutical waste.

Escalation

Action to be taken if a problem is identified
Escalate to the clinician caring for the patient and the perioperative team leader. If an allergy occurs, remove the prep solution, and monitor the reaction. The reaction needs to be documented and a Datix completed. If further skin preparation is required only do so under recommendation of the operating surgeon.

Provenance

Record:	5949
Objective:	To provide evidence-based recommendations for appropriate selection and use of skin preparation solutions.
Clinical condition:
Target patient group:	All surgical patients
Target professional group(s):	Midwives Secondary Care Doctors Secondary Care Nurses Allied Health Professionals
Adapted from:

Evidence base

References and Evidence levels:

National Institute For Health And Clinical Excellence (2019 last updated 2020) Surgical Site Infections: Prevention And Treatment: Clinical Guidelines [NG125], (https://www.nice.org.uk/guidance/ng125) Surgical site infections: prevention and treatment
One Together(2019) Surgical Skin Preparation - Quality Improvement Tool, Available in the resources section at: https://www.onetogether.org.uk (https://www.onetogether.org.uk/downloads/OneTogether%20Skin%20Prep%20QIR_2019.pdf)
Perioperative Care Collaborative (2018) The Perioperative Care Collaborative Position Statement - SURGICAL FIRST ASSISTANT, https://www.afpp.org.uk/careers/Standards-Guidance
Leeds Teaching Hospitals Trust (2018) WHO Safer Procedure Checklist and Surgical Site Marking, http://nww.lhp.leedsth.nhs.uk/common/guidelines/other_versions/5629.pdf
Leeds Teaching Hospital Trust (2018) Dual Role within the perioperative environment Standard Operating Procedure (SOP), http://nww.lhp.leedsth.nhs.uk/common/guidelines/detail.aspx?ID=4717
WHO guidelines for safe surgery : 2009 : safe surgery saves lives (2009)
http://apps.who.int/iris/bitstream/handle/10665/44185/9789241598552_eng.pdf?sequence=1

Approved By

Trust Clinical Guidelines Group

Document history

LHP version 2.0

Related information

Appendix 1 Properties of active agents in pre-operative skin preparations

	Active Antiseptic Agent
	Chlorhexidine Gluconate (CHG)	Iodophors (PI)	Alcohol
Mechanism of action	Disrupts cell membrane	Releases iodine which oxidises and substitutes cell material	Denatures cell wall protein
Preparation strength	0.5%; 2%	7 – 10%	70% isopropyl or ethyl alcohol preferred but can be 30-85%
Quick kill	High (up to 48hrs)		Rapid
Persistent activity	Moderate	Moderate	None
Use on eyes	No (damage to cornea)	Dilute 1:1 10% solution with balanced salts to make 5%	No
Use on ears	No (damages middle ear)	Yes *external (caution -* *ototoxic if it enters the inner ear)*	No
Use on mouth	Use 0.12% oral rinse	Yes	No
Use on genital area	No	Yes	No
Use on tissues	No	No	No
Contraindications	• Sensitivity or allergy	• Sensitivity or allergy	• Sensitivity or allergy
*Cautions*	*• Neonates*	*• Neonates* *• Inactivated in presence of blood* *Note: risk of iodine toxicity in repeat use in patients* *with thyroid disorders, pregnant/ breastfeeding* *women but unlikely to be a problem for single preoperative* *skin preparation* *• Neonates*	*• Neonates* *• Inactivated in presence of* *Blood*

(modified in Italic bold type) One Together(2019) Surgical Skin Preparation - Quality improvement tool, Available in the resources section at:
https://www.onetogether.org.uk/home/

Appendix 2 SURGICAL SITE – skin prep area dependent on surgical/ invasive procedure

Always follow Manufacturer’s Instructions for Skin Prepping Solutions

Abdomen

Start at umbilicus then discard this applicator/swab/sponge - work out in concentric circles. Cover up to nipple line and down to upper thighs and down abdominal sides dependent on procedure

Groin

Incision site then out in concentric circles to level of umbilicus down abdominal side, upper thigh and pubic region/ scrotum

Chest

From neck to below diaphragm, to include upper arm, axilla and across sternum/ spine of opposite side to incision if unilateral, dependent on surgery. If bilateral or midline, include both sides

Back

If prone neck to sacrum and down sides dependent on surgery

Do not use Chlorhexidine gluconate or alcohol skin prep on brain/ meninges/ spinal cord

Neck

Prep from incision site and out in concentric circles

Head/ Face/ Scalp

Do not use Chlorhexidine gluconate or alcohol skin prep near or on/in the eyes – it may cause corneal damage

Eyes must be protected when prepping the surrounding area (this can be using a simple ophthalmic ointment and a film shield). If it is necessary to prep the eyelids do so from medial to lateral then working out in half circles to bridge of nose, cheek and forehead with gentle strokes. Povidone- iodine antiseptic solution 5% i.e. Povidone- iodine 10% mixed with the same volume of 0.9% saline solution may be used. For intraocular use Povidone-iodine 5% may be used

On the scalp ensure the prep solution penetrates the hair and reaches the skin. There is a high risk of combustion with alcohol based preps as prep can take considerably longer to dry on hairy surfaces

Do not use Chlorhexidine gluconate or alcohol skin prep on the middle ear or external ear with perforated tympanic membrane as they are ototoxic and can cause sensorineural deafness if it comes into contact with the inner ear

Do not use povidone-iodine as skin prep in the ear canal as povidone-iodine can also be ototoxic if it enters the inner ear

Place cotton wool ball in the external ear canal prior to skin prep. Start with external ear then extend to edge of hairline, cheek and jaw. Remove cotton wool ball if operating through the canal and document

Do not use Chlorhexidine gluconate or alcoholic skin prep on mucous membranes e.g. mouth/ inner lip

Shoulder

Prep chest, neck, shoulder, upper arm, scapula, axilla - prepping the axilla last

Arm

For upper arm prep from mid forearm to shoulder including axilla, commencing at incision site - prepping the axilla last

Hand

Clean under fingernails prior to prep. Prep hand to mid forearm commencing with incision site. Complete one side of the hand prior to turning the hand then prep up the forearm in circular motions

Perineum/ anus

Prevent pooling of skin prep fluid under sacrum. Prep pubic region, then labia/scrotum to inner thighs. Prep anus last. Do not penetrate the anus with skin prep swab

Vagina

Do not use Chlorhexidine gluconate or alcohol skin prep on mucous membranes. Prevent pooling of prep fluid under sacrum. Prep pubic region to iliac crests then labia to inner thighs, prep vagina with clean skin prep swab, then the anus last

Hip

Start at incision site, working out in concentric circles to midline abdomen, to lateral costal margin, to buttock on affected side. Prep down the leg to knee, then prep groin and perineal area last (may require the leg raised during skin prep)

Knee

Elevate the leg. Prep circumferentially from incision site up to tourniquet (if used) and down to ankle.

Ankle/ foot

Clean under the toe nails prior to skin prep. Elevate the limb. Prep to mid-calf not forgetting between the toes

Appendix 3 Skin Preparation solutions

Appendix 4 Joint RCS/MHRA Statement on use of Topical Chlorhexidine for Skin Preparation Prior to Surgery (2015)

Statement on the use of topical chlorhexidine for skin preparation prior to surgery

Topical chlorhexidine is a common disinfectant used to prepare the skin prior to surgery in order to prevent surgical site infection. However, it has been reported to the College that some operating theatres may be using biocidal chlorhexidine, a form of the chemical registered with the Health and Safety Executive (HSE), rather than products registered as medicines with the Medicines and Healthcare Products Regulatory Agency (MHRA).
While NICE recommends either chlorhexidine or povidone-iodine for pre-operative antisepsis, operating theatres should be using the medicinally licensed product over those which are classed as a general disinfectant.
The Royal College of Surgeons and the MHRA recommends the use of licensed medicines to prepare the skin prior to surgery. The MHRA has issued the following clarification, which the College fully endorses:

Chlorhexidine - MHRA position

The manufacture and supply of a medicinal product containing chlorhexidine should be in accordance with Human Medicines Regulations. The product should have a marketing authorisation and there are restrictions on how it may be used.
Chlorhexidine is also available in a non-medicinal form which is extensively and legitimately used for non-medicinal purposes, including in a clinical setting. These versions of the product are not subject to regulation under the Human Medicines Regulations 2012.
The MHRA view is that chlorhexidine is classified differently for different presentations. These are:

Medical Use: Topical disinfectant for clinical use. (e.g. pre-operatively).
Medical Device: Disinfectant for medical equipment.
Biocide: General use as disinfectant (e.g. washing hands).

Where an authorised product exists this should be used in preference to another product as only it will be fully supported by risk-benefit analyses as to its use for that specific purpose.
MHRA would like to highlight that there are health risks associated with using chlorhexidine. Using the appropriately authorised product for its specific intended use, in accordance with the manufacturer’s instructions for use, is the best way of minimising harm.
Joint RCS/MHRA Statement on use of Topical Chlorhexidine for Skin Preparation Prior to Surgery — Royal College of Surgeons

Appendix 5 Surgical Skin Preparation Audit - Auditor to observe

Audit standard:
Auditor is to observe and complete the documentation for 5 procedures (annually).

Auditor:

Theatre/Procedure Room:

Date:

Lead Surgeon/Clinician:

Lead Anaesthetist:

Please return this form to Joan Ingram, Head of Nursing, Theatres and Anaesthesia CSU, 2nd Floor, Bexley Wing link corridor, St James's University Hospital, Leeds, LS9 7TF. Email: joan.ingram@nhs.net

Surgical Skin Preparation
1	Site of surgical procedure
2	Skin preparation solution selected	Solution:					Concentration:
3	Is the skin preparation solution selected suitable for use? Please refer to guideline (Appendix one and two)	Yes	No
4	If no please state why:
5	Is the person preparing the patients skin deemed ‘competent’? Please check guideline for definition.	Yes		No
6	Which staff group does the member of staff preparing the patients skin belongs to?	Operating Clinician			Scrub Practitioner	Surgical Care Practitioner (SCP)		Surgical First Assistant/ Advanced Scrub Practitioner (SFA/ASP)
7	Did the person preparing the patients skin carry out the preparation using the recommended technique. Please refer to the guideline (Appendix two)	Yes		No
8	If no please state technique used:
9	Was the skin prep solution removed from the sterile field immediately after use?	Yes		No
10	Was the skin prep solution allowed to dry prior to draping?	Yes		No
11	Has the prep solution been documented in the patient record of care?	Yes		No

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