Published: 4 June 2013
Safety Information
Trans-Tasman Early Warning System - Alert Communication
Topical tissue glues/adhesives and risk of deep tissue injuries
Products affected
Information for consumers and caregivers
Information for healthcare professionals
Data summary
What action is Medsafe taking?
How to report
Further information
Medsafe has received a case report from ACC of a patient who developed nerve and tendon damage after application of tissue glue to a skin laceration. The patient required surgical debridement and repair and prolonged rehabilitation to regain full function of the affected limb. It is likely that this patient had an unidentified tendon injury at the time of presentation which was exacerbated by penetration of the tissue glue into deep tissues. The nerve injury was attributed by clinical experts as being directly caused by the tissue adhesive/glue.
No other case reports of deep tissue damage from the administration of topical skin adhesives were identified.
Products affected
The following tissue glues/adhesives are notified in New Zealand.
| Product Name or Device Type | Sponsor |
|---|---|
| DERMABOND topical skin adhesive; DEAL Copy- Closure Medical | Johnson and Johnson Medical New Zealand Ltd |
| SurgiSeal topical skin adhesive | Culpan Distributors Ltd |
| Adhesive, soft tissue approximation | B Braun New Zealand Pty Ltd |
| Leukosan Adhesive | BSN Medical Ltd |
| Ethicon LLC, Adhesive, soft tissue approximation | Johnson and Johnson Medical New Zealand Ltd |
| Ethicon LLC (SL), Adhesive, soft tissue approximation | Johnson and Johnson Medical New Zealand Ltd |
| Ethicon Inc Omnex Surgical Sealant | Johnson and Johnson Medical New Zealand Ltd |
| Instruments – Medlogic – Liquiband Tissue Adhesive | Lifehealthcare Ltd New Zealand |
| Meyer Haake 02 | Medxus Ltd |
Information for consumers and caregivers
Skin glues/adhesives are a safe and effective treatment for many skin cuts/wounds.
Please contact your doctor if you (or your child) experiences on-going pain, redness or wound breakdown after having tissue glue applied.
Please also report any problems you have experienced with skin glues/adhesives to Medsafe.
Medsafe cannot give advice about an individual's medical condition. If you have any concerns about the use of tissue glue Medsafe encourages you to talk to your healthcare professional.
Information for healthcare professionals
Topical tissue adhesive/glues are safe and effective when used correctly on appropriate wounds. This case report acts as a timely reminder of the need to carefully explore wounds before skin closure and to follow the manufacturer's application instructions when applying topical tissue glues/adhesives.
- Select wounds carefully
The table below gives guidelines for appropriate wound selection
Table 1: Appropriate and inappropriate use of tissue adhesives1,2Appropriate wounds Inappropriate wounds Fresh (ie less than 6 hours old) Old (ie, > 12 hours old) Clean Dirty (eg, animal or human bites) No longer bleeding Crush wounds Small (generally ≤ 4cm long) Puncture wounds (as they can be deep) Easily identifiable edges which come together easily Wounds to the areolae of the breast Scalp wounds Tissues under tension due to regular movement (eg, knee or elbow joints) Deep wounds - only if cavities have been closed by subcutaneous sutures Lacerations of the hands or feet unless the affected areas are immobilised (as repetitive movements can break the adhesive bonds) - Caton-Richard (2011).Closure of minor wounds with tissue adhesive. Emergency Nurse 18(9):18-20.
- Kronfol R (2012). Superficial wound repair with tissue adhesives. Available at www.uptodate.com. Accessed 22 May 2013.
- Familiarise yourself with the manufacturer's application instructions
before applying skin glue.
- Be aware that skin glues can come in different applicators.
- Ensure that skin edges are opposed and the glue applied thinly to the skin surface only.
- Take care to ensure that the tissue glue does not enter the wound itself. If tissue penetration occurs, excess glue should be removed immediately to prevent damage to deep tissues.
- Report any adverse events associated with the use of tissue glues/adhesives to Medsafe
Data summary
Medsafe has received a case report of a patient who developed nerve and tendon damage after application of tissue glue to a laceration. The patient required surgical debridement and repair and prolonged rehabilitation to regain full function of the affected limb.
Topical tissue glues/adhesives (also known as skin glues) are used to treat selected superficial skin wounds. They consist of liquid cyanoacrylate monomers which polymerise into long chains that hold wound edges together, when they come into contact with blood or a wound surface.
Topical tissue glues are generally considered to be a safe and effective method to close skin wounds, when appropriate wounds are selected and the skin glue is applied accurately. Advantages over the use of sutures include lack of pain, low infection rates, reduced procedure times, ease of wound care and no need for follow-up.
Side effects of tissue glues/adhesives include sensation of mild heat at the time the glue is applied and an increased risk of wounds re-opening compared to the use of sutures. If the glue is applied to sub-dermal layers it may elicit a foreign body reaction which can cause chronic pain and inflammation.
It is unclear how commonly deep tissue injuries occur after application of topical tissue adhesives/glues. No other case reports were identified in the literature.
What action is Medsafe taking?
Medsafe will continue to monitor this issue and will issue further advice if necessary.
How to report
| Post | Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415. |
| Online | Complete a Report |
| Devices | |
| Fax | +64 4 8199 6806 |
Further information
Health professionals are advised to consult the manufacturer’s instructions for further information on the use and possible side effects of specific superficial tissue glues/adhesives.
