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Trial Detail

CUHK_CCRB00488

2015-11-18

Prospective

2015.353-T

Nethersole school of Nursing

Eliza Wong

Jessica Lui

Act as the sponsor's legal representative in relation to some or all of the trial sites

Eliza Wong

Nethersole School of Nursing , The Chinese University of Hong Kong, Shatin, Hong Kong

39438098

elizawong@cuhk.edu.hk

The Chinese University of Hong Kong

HKSAR

Eliza Mi Ling Wong

8/f , Esther Lee building, The Chinese University of Hong Kong, Shatin, Hong Kong

39438098

elizawong@cuhk.edu.hk

The Nethersole School of Nursing

Hong Kong SAR

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

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

以 "外科癒合劑" 或 "縫針" 方法處理傷口之成效研究計劃

Hong Kong

Yes

2015-11-10

Joint CUHK-NTEC Clinical Research Ethics Committee

2015.353-T

lacerated wound

Procedure

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 with very light brushing motion. 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 approximately 2.5 minutes after the application of the final layer.

NA

NA

Average about 15-20 minutes for the whole wound closure

once

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 eversion of skin edges) (HA COC A&E Suture Manual, 2013).

NA

NA

average about 15-25 minutes

once

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.

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

7

17

Both Male and Female

Observational

Randomized

Parallel 1:1 ratio by using computer generated method with block size four.

Not Applicable

Not Applicable

Parallel

1

2015-11-30

30

Not Yet Recruiting

 Cosmetic Visual Analog Scale (CVAS);

observation

day 7, day 14 and 1 month

 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)

observation and self administer

before and after the procedure for perceived pain and anxiety; dar 7, 14 and 1 month for the WES

No

2016-04-01

ChiCTR-IOR-15007421

2015-11-18

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