Suture vs Staples for Skin Closure After Liver Resection

Not Applicable

Completed

• Conditions: Closure of the Skin After Liver Resection
• Interventions: Procedure: Suture Group; Biological: Staple Group (control)

• Registration Number: NCT02046239
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2015-01-01
• Study Completion: 2015-01-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture Group	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.
Staple Group	Staple Group (control)	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.

Primary Outcome Measures

Name	Time	Method
Post-operative infection time	1 year

Secondary Outcome Measures

Name	Time	Method
Time taken for skin closure	12 months

Trial Locations

Locations (1)

Leeds Teaching Hospital NHS Trust; 🇬🇧 Leeds, United Kingdom