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

The effectiveness of wound closure using Dermabond versus sutures for lacerated wound closure for paediatric patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15007421
Enrollment
Unknown
Registered
2015-11-18
Start date
2015-11-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lacerated wound

Interventions

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 approximate
(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
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

Sponsors

Eliza Wong
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactEliza Mi Ling Wong
elizawong@cuhk.edu.hk+852 39438098

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026