None listed
Conditions
Brief summary
This pilot study aims to compare a new wound closure technique — called boot-lace assisted tissue expansion — against standard reconstructive surgery (skin grafts or flaps) for closing skin wounds on the arms, legs, and trunk in adults following skin cancer removal or trauma. Who is it for? You may be eligible for this study if you are an adult presenting for elective excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) or post-traumatic event. Study details Participants will be randomly allocated to either boot-lace assisted wound tissue expansion, or conventional techniques including local or regional flap, full-thickness skin graft or split-thickness skin graft. Participants assigned to the boot-lace technique group may be further randomly allocated to undergo the Khouri technique, which involves small needle perforations made in the surrounding skin to further improve its elasticity. Outcomes assessed will include scar quality, wound healing time, pain, complications, cost effectiveness, and patient satisfaction. It is hoped that findings from this study inform future surgical practice for skin cancer removal and post-trauma events.
Interventions
The intervention:
This trial involves two surgical interventions compared in a parallel-arm randomised design:
Control Arm (Group 1) — Conventional Reconstruction:
Standard surgical closure of post-excision or post-trauma skin defects using one of three techniques selected by the treating surgeon based on clinical suitability: local or regional flap (Group 1a), full-thickness skin graft (FTSG) (Group 1b), or split-thickness skin graft (SSG) (Group 1c).
Intervention Arm (Group 2) — Boot-Lace As
The intervention: This trial involves two surgical interventions compared in a parallel-arm randomised design: Control Arm (Group 1) — Conventional Reconstruction: Standard surgical closure of post-excision or post-trauma skin defects using one of three techniques selected by the treating surgeon based on clinical suitability: local or regional flap (Group 1a), full-thickness skin graft (FTSG) (Group 1b), or split-thickness skin graft (SSG) (Group 1c). Intervention Arm (Group 2) — Boot-Lace Assisted Immediate Tissue Expansion: A surgical wound closure technique in which suture material is applied in a boot-lace (shoelace) crossing configuration across the wound defect to distribute tension multi-directionally, harnessing the viscoelastic properties of skin (mechanical creep and stress relaxation) to achieve direct wound closure without donor site harvest. Participants in Group 2 will be further allocated to: Group 2a: Boot-lace technique alone Group 2b: Boot-lace technique combined with the Khouri Percutaneous Mesh Expansion (PME) technique, in which multiple small needle perforations are made in the surrounding dermo-epidermis to enhance local tissue elasticity and expand the available tissue reservoir for closure Delivery: Both interventions will be delivered by doctors from the plastics and reconstructive surgery team at Gold Coast Health, who have training and extensive experience in this field. The first 10 surgeries in Group 2 will be performed or directly assisted by consultant surgeons, while the following 10 surgeries will be performed by PHOs or registrars under consultant supervision. Frequency and length: Each person undergoes a single surgical procedure, unless additional procedures are medically deemed necessary. Boot lace technique may add minimal additional operative time compared with conventional reconstruction. operative time will be formally recorded as a secondary outcome measure for comparison between arms. Post-operative wound management will continue until the wound no longer requires dressings, with the time to this endpoint recorded as a primary healing outcome. Location: Surgical procedures may be performed at Gold Coast University Hospital, Robina Hospital, or Varsity Day Surgery Hospital. Follow up may be at Gold Coast University Hospital or Robina Hospital clinics. Adherence: Participants will be scheduled for follow-up appointments at defined time points. Appointment reminders will be sent out via phone call or text-message. Where participants are unable to attend in person, telephone follow-up will be arranged where clinically appropriate. Any intraoperative reversion to conventional technique, requirement for additional procedures, or other protocol deviations will be documented in the case report form and reported to the principal investigators for review.
Sponsors
Anna Jolly Neriamparambil works at Gold Coast health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Adult patients (18 years or older) presenting for elective excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) or post-traumatic event. • Post-excision or post-trauma defect located on the upper or lower limbs (including dorsum of hands and feet) or trunk (anterior or posterior). • Defect deemed not directly closable by conventional technique by the treating consultant. • Capacity to provide informed consent. • Ability to attend follow-up appointments.
Exclusion criteria
• Defect location: face, ears, knees, ankles, plantar foot, volar hands, or flexion aspects of major joints (elbows, popliteal fossa, axillae — subject to investigator review). These sites carry elevated risk of functional compromise, contracture, or poor cosmesis with tension-based closure techniques. • Fitzpatrick skin type 5 or 6 (pilot phase — due to elevated keloid and hypertrophic scarring risk). • Melanoma, inadequately excised or recurrent BCC/SCC, or soft tissue malignant tumours requiring post-excision reconstruction. Complex oncological management requirements and potential need for further excision or adjuvant therapy may confound wound closure outcomes. • Long-term systemic corticosteroids exceeding 10mg Prednisolone daily or equivalent. Chronic steroid use impairs wound healing and increases risk of skin fragility, dehiscence, and infection. • Fragile skin conditions (e.g. dermatoporosis, cutaneous T-cell lymphoma). Compromised skin integrity increases the risk of tissue tearing and wound failure under the tension required by the boot-lace technique. • Age greater than 80 years. Advanced age is associated with impaired wound healing, skin fragility, and increased operative risk. • Active chemotherapy. Cytotoxic agents impair wound healing and increase infection risk, confounding outcome assessment. • Previous radiation to the operative site. Radiation-damaged tissue has impaired vascularity and healing capacity, increasing complication risk with tension-based closure. • Personal history of keloid or hypertrophic scarring. Pre-existing tendency to pathological scarring would confound scar outcome assessment and may be worsened by wound tension. • Prior skin grafts within 10cm of the planned defect. Previous grafting alters local tissue architecture and elasticity, compromising the tissue expansion required for boot-lace closure. • Requirement for further excision or skin grafts/flaps at time of index procedure. Co-existing reconstructive requirements would confound outcome attribution to the trial technique. • Intraoperative complications (infection, haematoma, bleeding) altering healing trajectory — exclusion from trial but not from clinical care. Complications such as uncontrolled bleeding or infection would independently affect wound healing outcomes, confounding trial results.
Outcome results
None listed