Suture vs Staples for Skin Closure After Liver Resection

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Controlled Trial to Compare Subcuticular Suture vs Staples for Skin Closure After Liver Resection.

Conditions
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Closure of the Skin After Liver Resection

Intervention / Treatment
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* Procedure: Suture Group
* Biological: Staple Group (control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Staple Group<br>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. | Biological: Staple Group (control)<br> <br> |
| Experimental: Suture Group<br>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. | Procedure: Suture Group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative infection time |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken for skin closure |  | 12 months |