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Comparing the results of different skin closure techniques in children after elective surgery.

Prospective Randomised Controlled Trial Comparing Parental Satisfaction and Clinical Outcome Measures for Paediatric Skin Closure Techniques

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000158369
Acronym
PST Trial
Enrollment
295
Registered
2017-01-30
Start date
2017-03-16
Completion date
2018-11-15
Last updated
2021-12-27

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

Conditions

None listed

Brief summary

A prospective randomised controlled trial comparing skin closure of surgical incisions in children using either a wound dressing only, adhesive tape (SteriStrips) or adhesive glue (Dermabond). The choice of which of these techniques is used is usually dependent upon the surgeon’s preference and there is little evidence to show which of the three is better. This study will help to determine which of these three techniques, if any, is better and will help paediatric surgeons choose the best skin closure technique for their patients. Parents of children presenting for elective surgical procedures will be approached for enrolment. Participating children will then be randomised to have surgical incision skin closure with sutures and then either adhesive tape, adhesive glue or a simple wound dressing. Postoperatively, children will be followed up at 2 weeks via telephone survey where a parental satisfaction survey in terms of the wounds will be performed. Parents will also be asked questions related to: 1. Wound healing 2. The presence of any complications such as wound infection 3. Requirement to see a doctor regarding the wound postoperatively, 4. Time taken for each skin closure type to come off 5. Any parental concerns regarding the type of skin closure used. Parents will also be asked to fill out an online survey in which they will rate the cosmetic outcome of the wound. Parents unable to be reached via telephone will have a link emailed to their email address to complete the entire survey online. There will be a second followup at 6 weeks postoperatively where children will be reviewed by a paediatric surgeon in the Outpatients Clinic to assess the cosmetic outcome of the surgical wound and parents will be asked to complete a survey in hard-copy or on an iPad about the cosmetic outcome of the wound and overall parental satisfaction with the skin closure technique. Data collected will then be used to assess for differences between the three patient groups including blinded photographic assessment of the surgical wounds. This project will aim to look for differences between the three groups in terms of cosmetic outcome (as rated by the parents and a blinded paediatric surgeon assessor), differences in wound infection and wound breakdown rates and a comparison of parental satisfaction with the skin closure technique. It is hypothesised that, as all three wound closure techniques are used in clinical practice, it is likely that there will be minimal difference between the three groups. However these techniques have not been compared in a controlled trial.

Interventions

Intervention Arm 1 - skin closure of surgical wound incision with adhesive glue (DERMABOND) Patients randomised to this intervention group will have have skin closure of the surgical wound incisions with DERMABOND adhesive glue once the wound has been closed with sutures. There will be no alteration to the surgery itself. The skin incision will be closed using the DERMABOND adhesive glue by the paediatric surgeon/paediatric surgical registrar performing the operation. The DERMABOND adhesive glu

Intervention Arm 1 - skin closure of surgical wound incision with adhesive glue (DERMABOND) Patients randomised to this intervention group will have have skin closure of the surgical wound incisions with DERMABOND adhesive glue once the wound has been closed with sutures. There will be no alteration to the surgery itself. The skin incision will be closed using the DERMABOND adhesive glue by the paediatric surgeon/paediatric surgical registrar performing the operation. The DERMABOND adhesive glue is a liquid glue packaged in a ready-to-use small plastic vial with an applicator at the tip. The liquid glue is applied at the wound edge to bring the two wound edges together and hold it in place and is then left to dry for a minute or two. The approximate volume used for closing the wound incision will be determined by the treating surgeon. There is no follow-up treatment required to remove the glue itself; it will fall off after a few days. Children participating in the study as well as their parents/guardians will be told that the skin was closed with DERMABOND adhesive glue at the completion of the operation. Intervention Arm 2 - skin closure of surgical wound incision with adhesive tape (SteriStrips) Patients randomised to this intervention group will have have skin closure of the surgical wound incisions with adhesive tape (SteriStrips) once the wound has been closed with sutures. There will be no alteration to the surgery itself. The skin incision will be closed using the adhesive tape (SteriStrips) by the paediatric surgeon/paediatric surgical registrar performing the operation. SteriStrips are small strips of adhesive tape. The adhesive tape is applied to bring the two wound edges together and hold them in place. They are applied to the skin after the wound has been closed. The number of strips of adhesive tape required for the wound incision will be determined by the treating surgeon. There is no follow-up required to remove the SteriStrips themselves; they will fall off after a few days. Children participating in the study as well as their parents/guardians will be told that the skin was closed with adhesive tape (SteriStrips) at the completion of the operation.

Sponsors

Department of Paediatric Surgery, Monash Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

Paediatric patients (0-18 years) presenting for an elective paediatric surgical procedure at Monash Children's Hospital

Exclusion criteria

Repeat elective operations

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026