Suture vs Staples for Skin Closure After Liver Resection

Closure of the Skin After Liver Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046239
• Other study ID #: GS13/10722
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: January 1, 2015

Study information

• Verified date: July 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 1, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Closure of the Skin After Liver Resection

Intervention

Procedure:
• Suture Group

Biological:
• Staple Group (control)

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative infection time		1 year
Secondary	Time taken for skin closure		12 months