904 Muscle Biopsy

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes the safety and procedural measures for muscle biopsy collection.

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Definitions

Muscle Biopsy: ensemble of similar cells from same origin that together carry out a specific function.

Tissue: ensemble of similar cells from same origin that together carry out a specific function.

Procedures

1. Investigator or delegated study staff member(s)

• Within scope of licensure, the investigator or delegated staff member are responsible for the preparation, collection, and processing of a muscle biopsy.
• The biopsy will be completed as specified by study protocol.
• If the study protocol does not provide specific instructions, the investigator or delegated staff will follow the procedure below.

2. Safety

• Personal protective equipment is required during the procedure and while handling sample(s). Universal precautions are followed throughout the procedure and during tissue processing.

3. Supplies

• Biopsy device
• Razor
• Sterile drape
• Sterile surgical gloves
• Gloves
• Antiseptic soap/alcohol swabs
• Betadine Lidocaine/Xylocaine
• Saline
• Luer Lock Syringe (Suction)
• Syringe(s)

4. Performing Biopsy

• Assemble equipment.
• Assess the participant’s understanding of the study and procedure to be done.
• Explain the purpose, risks, and procedure to the participant.
• Select site for purpose of sample collection per protocol.
• Prepare the site by shaving (as needed) and cleaning with antiseptic soap or alcohol swabs.
• Clean the site, several centimeters, around the incision site with betadine or an antiseptic fluid.
• Numb the skin surface of the incision site.
• Inject local anesthetic (i.e. Lidocaine, Xylocaine, etc.) just beneath the skin where the biopsy will take place.
• Test numbness of site by gently tapping the site and asking participant if they feel the area.
• Using a sterile scalpel, make a small incision down to and slightly through the covering of the muscle.
• Place the sterilized biopsy device through the incision site into the muscle tissue.
• Apply brief suction with syringe into the biopsy device.
• Cut suctioned tissue off, retaining inside the biopsy device.
• Withdraw biopsy device. (This leaves tissue sample within the device.)
• After the biopsy device is withdrawn, apply pressure with gauze to the incision site.
• Apply compression bandage for 15 minutes and ice/cold pack for 5 minutes.
• Once bleeding is controlled, close the incision site with Steri-Strips and cover with a small sterile dressing.
• Provide verbal and written follow up instructions for care after the procedure. Verbal and written instructions should include the following:
  • Leave Steri-Strips on 5-7 days.
  • Avoid vigorous activity during the first 24 hours after the procedure.
  • Do not shower or get incision wet during the first 24 hours after the procedure.
  • Refer to after care instructions as needed.
  • Contact designated research personnel if there are any complications.

5. Suggested Informed Consent Language

You will have a muscle biopsy performed on your ____________ muscle as part of your assessment to determine ____________. You should refrain from exercise the 3-days prior to this muscle biopsy since exercise is known to affect muscle proteins. The muscle biopsy procedure consists of initially shaving a two by three-inch square on your ______ and cleansing this area with iodine. The iodine may temporarily leave your skin with a yellowish tinge. A local anesthetic, much like that used at the dentists’ office (insert anesthetic agent here) will be injected just beneath the skin in an area the size of a nickel. This injection may feel like a bee sting but will numb the skin. A small incision of approximately ______ will then be made in the numbed area. A sterile biopsy device about the diameter of a ______ will then be inserted about ___ inch into your ______ muscle. A piece of muscle about (insert size and example here) The time to collect the sample will be (insert time here). You will then have pressure applied to the biopsy site for 15 minutes and a cold pack applied for 5 minutes. The incision will be closed with a steri-strip and a bandage; a temporary pressure wrap will also be applied to your leg. This visit will take approximately (insert time here).

In rare instances, we do not obtain the minimal amount of muscle needed for analysis (insert amount here). If this occurs, we will ask you if we have permission to take another biopsy through the same incision site (you will only have 1 incision site). Whether you agree or decline this second biopsy attempt you will still be compensated for the visit, regardless of your decision.

Before leaving, you will be given written instructions on how to take care of the biopsy site. You will be instructed to leave the pressure wrap on for 2-4 hours and leave the steri-strips on for 5-7 days. You should avoid vigorous, strenuous leg exercises (e.g., leg squatting exercises) during the first 24-hours post-biopsy. You should also avoid showering or getting the incision site wet during the first 24-hours post-biopsy. If you have any questions or concerns regarding post-biopsy maintenance, at any time, you should contact (insert PI/study physician contact here).

Risks and Discomforts

Muscle Biopsy Procedure - Possible risks are a slight chance of fainting, a small risk of infection, the possibility of injuring a blood vessel or nerve, and muscle soreness with bruising. If you have a previously unrecognized allergy, you may have an allergic response to the injected anesthetic used in the current study. You will also feel a stinging sensation during the injection of the anesthetic and may feel a sensation of pressure when the needle is inserted into the muscle. You understand that no stitches are required to heal the incision, but that you will be left with a small scar at the site.

References: Bergström, J. (2009). Percutaneous Needle Biopsy of Skeletal Muscle I. Physiological and Clinical Research, Scandinavian Journal of Clinical and Laboratory Investigation, (35)7, 609-616.

Attachments: None

Appendices: None

Approver: Director, CTRU and Clinical Partnerships