A Randomised Controlled Trial to Compare Subcuticular Suture vs Staples for Skin Closure After Liver Resection.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Post-operative infection time
Study Overview
Brief Summary
Closure of the skin after liver resection (surgery to remove part of the liver) may be achieved by one of several methods. The standard method at our institution is to use stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous absorbable suture may be used to "sew" the skin together.
The ideal method of closure should be safe, effective, associated with minimal patient discomfort and have a good cosmetic result. At present, there is no scientific evidence to describe which method is most suitable following liver resection.
The primary aims of this study is to investigate which method (subcuticular sutures vs staples) offers the best result in postoperative rate of (1) skin infection, (2) skin dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we are interested in which method is best for patient satisfaction and cosmetic appearance and which method is most cost effective.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients undergoing liver resection surgery for benign or malignant aetiology
- •All patients undergoing surgery as a living liver donor.
Exclusion Criteria
- •Any patient with an active wound infection
- •Any patient with an active incisional wound hernia from previous surgery
- •Synchronous bowel/liver surgery
- •History of keloid formation
Arms & Interventions
Staple Group
Staple Group: At the end of the operation, the skin will be closed using stainless steel staples, which is standard clinical practice at St. James's University Hospital. Approximately ten days after the operation, the staples will be manually removed; this is normally performed by the patients GP.
Intervention: Staple Group (control) (Biological)
Suture Group
Suture Group: At the end of the operation, the skin will be closed using absorbable surgical suture. Manual removal of this suture is not required because the thread is self-absorbable.
Intervention: Suture Group (Procedure)
Outcomes
Primary Outcomes
Post-operative infection time
Time Frame: 1 year
Secondary Outcomes
- Time taken for skin closure(12 months)