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Comparison of absorbable deep dermal versus nonabsorbable interrupted sutures in emergency department wound closure in a paediatric randomised controlled trial study

Comparison of absorbable deep dermal versus nonabsorbable interrupted sutures in emergency department wound closure in a paediatric randomised controlled trial study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000419268
Enrollment
112
Registered
2018-03-22
Start date
2018-05-01
Completion date
2019-04-30
Last updated
2018-06-11

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

Conditions

None listed

Brief summary

Children presenting to the emergency department with lacerations is very common. We wish to conduct a study that compares two types of stitching techniques (called 'deep dermal suturing' and 'simple interrupted suturing'). Both of these methods are commonly used, however it has not been concluded which technique is better for healing lacerations in the child population. Participants will be assigned to receive either the deep dermal technique or the simple interrupted technique to close their wound. Participants (or their family or guardians) will not be aware of which group they are in. After the stitching is complete, the wound will be bandaged for up to 7 days, and participants will be instructed not to remove the bandage or inspect the wound at any time. Participants will be asked to return to an assigned clinic 3 days, 7 days and 3 months after the initial presentation. Here, wounds will be assessed by staff and stitches may be removed (this may require anaesthesia or sedation). If the wounds are found to have incomplete wound closure or dehiscence, a second suture will be administer and patients will be asked to come back at day 14 for reassessment. Three months later, the scar from the wound will be photographed, and medical staff will be asked to rate the appearance of the scar. We aim to determine which of these two methods are superior, considering the economic cost, infection rates, cosmetic outcome and time for wound closure. With these factors in consideration, we hypothesise that there is a clinically significant difference between the deep dermal absorbable and simple interrupted nonabsorbable sutures.

Interventions

This study will analyse Vicryl Rapide (absorbable) versus non­absorbable Nylon sutures in the closure of wounds in the emergency department setting. Participants receiving absorbable sutures will have their wounds closed by the deep dermal wound closure technique. This involves inserting the suture first from deep within the wound, from one edge and exiting  just under the epidermis. The same suture is inserted from the opposite edge under the epidermis and exit deep within the wound. The stitch

This study will analyse Vicryl Rapide (absorbable) versus non­absorbable Nylon sutures in the closure of wounds in the emergency department setting. Participants receiving absorbable sutures will have their wounds closed by the deep dermal wound closure technique. This involves inserting the suture first from deep within the wound, from one edge and exiting  just under the epidermis. The same suture is inserted from the opposite edge under the epidermis and exit deep within the wound. The stitch is then tied with the knot buried deep in the wound. This is repeated in an interrupted fashion till the wound is completely closed. We estimate that most wounds will be closed in 20 minutes, depending on the type of wound in sustained by the participant, whether it requires cleaning, how settled the child is. Emergency department staff will be briefed on what this study involves, and those wishing to participate will do so. Doctors (excluding interns) working in the emergency department will complete the suturing. Nursing staff will assess the wound at follow-up visits. The wound will be bandaged up to 7 days after the wound closure. This is to ensure that the parents are blinded in regards to the types of interventions performed. Participants and their parents/guardians will be reminded by phone calls and/or text messages to attend their follow-up appointments. Staff at the appointments will remind them of the study requirements (e.g. do not wash the wound themselves), and all participants are provided with contact information of the investigators should they have questions throughout the study. The child participant will then be asked to return to an assigned clinic 3 days, 7 days and 3 months after the initial presentation. Here, wounds will be assessed and checked by staff for infection and stitches may be removed (this may require anaesthesia or sedation). Three months later, the scar from the wound will be photographed, and medical staff will be asked to rate the appearance of the scar.

Sponsors

Dr Gabriel Akra
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
1 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

Children between the ages of 1 year and 17 years. Single laceration in a child in the above age bracket. Lacerations located on any region of the body. Laceration lengths between 1cm and 5cm. Lacerations considered suitable for suturing.

Exclusion criteria

Children or parent/carer who decline to be part of the study. Children who elect to have their surgery done outside the ED. Children whose wounds need to be closed by non-ED staff. Children who have chronic medical conditions that may impact the wound healing process. This includes type one and two diabetes mellitus, heart failure, patients who are taking immunosuppresives or have bleeding disorders. Children who came in with multiple lacerations or deep lacerations affecting the underlying structures such as ligaments and neurovascular supplies. Children who have severe needle phobia. Children who will struggle to attend outpatient appointments due to logistic issues.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026