Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04073030
Other study ID # KSUMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date July 30, 2019

Study information

Verified date August 2019
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cyanoacrylate is used in the manufacturing of surgical adhesives, nail glue and super glue. After contact with cotton or wool, among other substances, a reaction is ignited, inflicting thermal damage to the skin underlying clothes. Nine papers have been published about such an incidence, majority of which involve children. In this paper, a four-year-old girl suffering from mixed-first-and-second degree burns due to cyanoacrylate spillage over the digits, anterior aspect of the right thigh and a patch of the skin on the left upper abdomen, spanning 4% of the total body surface area. The clothes were forcefully removed by the mother and shampoo was applied over the area. In the ER, irrigation with normal saline was done followed by dressing with paraffin- impregnated gauzes and silver sulfadiazine. Volar slabs were placed on the hands. The dressing in the hands was later changed to fusidic acid as the burn healed. Silicone sheet dressing was initiated twenty-eight days later after complete healing of the burned skin. An experiment conducted by the authors showed no difference in the pH of different cyanoacrylate products. The pH was not changed after applying shampoo over the nail glue immersed dip-stick.

This paper aims to improve awareness about proper first-aid management which predicts the quality of the outcome. Further emphasis is required on providing a safe environment for the children and clear, comprehendible warning of hazards on the label of the cyanoacrylate based-products.


Description:

Many household beauty products are used daily and are deemed safe for human use, such as cyanoacrylate glue. Originating as an organic monomer, it is utilized as super glue, tissue adhesive and attachment of artificial nails. It has found remarkable fame during Vietnam War as an adhesive for closure of organs and skin injuries. However, reports of toxicity had dampened its employment. Different forms such as methyl 2-cyanoacrylate and ethyl 2-cyanoacrylate are available as super glue. Butyl-2- cyanoacrylate until recently, was the only commercially available form. 2-octyl-cyanoacrylate was approved by the US FDA in 1998 as tissue adhesive and for skin closure due to low toxicity and skin reaction. We present a case of a child who suffered from burns due to spillage of nail glue over her clothes and managed in a tertiary care university hospital. Nine reports have been published in the literature about cyanoacrylate-mediated burns to the moment of typing this paper. To our knowledge, this is the first reported case in Saudi Arabia.

A four-year-old girl, not known to have any medical illnesses, arrived to the emergency department after she spilled nail glue over her abdomen, right thigh and both hands. The mother promptly removed her cotton clothes, which were stuck to the body, and applied shampoo over the involved area. No irrigation was done at home. In the ER, she was assessed and examined. Her vital signs were stable. A total body surface area of approximately 4% was affected by first-to-second-degree burns. the involved areas were a) Patches of the volar and dorsal aspect of all fingers proximally reaching the metacarpophalangeal joints, b) A 5 x 3.5 cm area of the middle anterior aspect of the right thigh and c) A patch of 2 x 5 cm affecting the upper left aspect of the abdomen and erythematous area near the left lower aspect of the umbilicus. No blisters were found. Irrigation using four liters of cool normal saline was done and the affected areas were dressed using paraffin- impregnated gauze over a layer of silver sulfadiazine. Volar slabs were applied for both hands. The child was admitted for twenty-four hours for observation and analgesia. Both hands were kept elevated and frequently assessed for capillary refill. The patient was then followed up by the plastic surgery team weekly in the dressing clinic. Three days following the incidence, silver sulfadiazine cream was substituted with topical fusidic acid 2% as the injury showed good healing. Twenty-eight days later, the burned areas completely healed without hypertrophic scarring. Silicone sheet dressing was started.

Cyanoacrylate is composed of a cyano group and an ester formed by an acryl acid, alcohol and a double-bounded central carbon atom. The monomers solidify after a rapid polymerization when mixed with weak alkaline material via an exothermic reaction. Many factors catalyze this process, where the double bond is broken, such as chemicals and electromagnetic radiation. Relevant examples include cotton and wool. Ample amount of hydroxyl groups for the polymerization is provided by the β-linked glucose units that form cotton. Due to the catalytic effect of cotton, the heat accumulates rapidly with even a small amount of the fabric. A process culminating into spontaneous ignition of clothes harming the skin in contact. In an effort to further study the changes accompanying cyanoacrylate application, the authors conducted an experiment using urinary dip- sticks to note any pH changes, which is being conducted for the first time. Three different cyanoacrylate compounds were used; The same nail glue used by the family, super glue and a surgical adhesive. After the application of each compound on a separate dip- stick for a minute, no alteration in the color implying pH change was noted. To simulate the conditions of this case report, a small amount of shampoo was added to a dip- stick coated with the nail glue. However, a similar result was found. Indicating that no difference in pH exists among the different cyanoacrylate compounds.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date July 30, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- This is a case report. We did not specify inclusion criteria.

Exclusion Criteria:

- This is a case report. We did not specify exclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
This study is not interventional
This study is not interventional

Locations

Country Name City State
Saudi Arabia King Saud University Medical City Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Qutaiba Nazar

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing Clinical judgement Up to 45 days
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A