The effectiveness of wound closure for lacerated wound closure for paediatric patients: a randomized controlled trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IOR-15007421
• Date of registration: 2015-11-18
• Prospective Registration: Yes
• Primary sponsor: Eliza Wong
• Public title: The effectiveness of wound closure for lacerated wound closure for paediatric patients: a randomized controlled trial
• Scientific title: The effectiveness of wound closure using Dermabond versus sutures for lacerated wound closure for paediatric patients: a randomized controlled trial
• Date of first enrolment: 2015-11-30
• Target sample size: Two groups:15;(to be continued):0;Control:15;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=12527
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Eliza Wong
• Affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong

• Name: Eliza Mi Ling Wong

Key inclusion & exclusion criteria

Inclusion criteria: The inclusion criteria are listed as follows: (a) Chinese pediatric patients, 7 years to 17 years; (b) with sustained laceration wound of <5 cm in length but without deep structure injury (bone and joint involvement or neurovascular damage to the tissue being repaired); and 3) availability of parent consent.
Exclusion criteria: The exclusion criteria are listed as follows: (a) underlying structural injury (e.g., muscle, tendon, bone, joint, or neuro-muscular injury, and scalp wounds); (b) complicated wound (severely crushed injury or stellate lacerations in areas with dense natural hair or under prolonged moisture or friction); (c) injury in mucosal surfaces, across muco-cutaneous junctions (e.g., oral cavity and lips), or skin, which may be regularly exposed to bodily fluids; d) high risk of infection (heavily contaminated, actively infected wounds, animal bites, or wounds sustained for more than 12 hours, and wound requiring debridement to remove nonviable tissue); e) high tension (e.g., chin) or deep wound that required deep sutures (e.g., torso or joint); f) eyelid or peri-orbital laceration; g) known hypersensitivity to tissue adhesive; and h) psychiatric cognitive disorder indicated in medical record (such as autism and mental retardation); h) wound that have potentially important consequences as perceived by parents.

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

lacerated wound

Intervention(s)

Two groups:Using tissue adhesive for wound closure. The nurse will use tissue adhesive (Dermabond) to close wounds of the patients in the intervention group. Procedures include holding the approximated skin edges of wound closed with gloved fingers or sterile forceps and then applying the adhesive over the skin surface(to be continued):Application of multiple layers (at least two) onto the dry wound is required, and 30 seconds must be allowed between applications for adequate polymerization. Then, the wound should be maintained for 60 seconds after the application of the final layer. Full apposition strength is expected to be achieved at&;Control:Using suture for wound closure. Wound preparation will be conducted under local anesthesia by using 1% lignocaine at a maximum dose of 3 mg/kg. Interrupted suture with nylon is the most common skin suturing method to achieve good wound apposition (no dead space, equal bite, fine adjustment, and slight e;

Primary Outcome(s)

Cosmetic Visual Analog Scale (CVAS); to be measured at day 7, day 14 and 1 month;

Secondary Outcome(s)

Wound Evaluation Score (WES);Wong- Baker FACES Pain Rating Scale (WBS);Short Form of the Chinese Version of the State Anxiety Scale for Children (CSAS-C) by observation and self administer, at before and after the procedure for perceived pain and anxiety; dar 7, 14 and 1 month for the WES;

Secondary ID(s)

CUHK_CCRB00488

Source(s) of Monetary Support

Nethersole school of Nursing