Suture vs Staples for Skin Closure After Liver Resection

NCT ID: NCT02046239

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2015-01-01

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.

Detailed Description

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Conditions

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Closure of the Skin After Liver Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Staple Group (control)

Intervention Type 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.

Group Type EXPERIMENTAL

Suture Group

Intervention Type PROCEDURE

Interventions

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Suture Group

Intervention Type PROCEDURE

Staple Group (control)

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GS13/10722

Identifier Type: -

Identifier Source: org_study_id

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