NCT01907542

Brief Summary

Background Stapled skin closure is frequently performed following open colectomies. However, its pain and cosmetic outcomes have been suboptimal. Monocryl sutured skin closure has been shown to be cosmetically superior and does not require removal of the sutures. But its association with wound infection has been questioned Aims This study aims to compare the outcomes using skin stapler or Monocryl suture in the skin closure following open colectomy. Hypotheses We believe Monocryl suture is associated with reduced pain and better cosmesis. Methodology Inclusion criteria: All patients who underwent elective open colectomy for various etiologies Exclusion criteria: i) Emergency laparotomies ii) Patient who require the creation of a stoma After consenting for the trial, patients will be randomized into either the skin stapler or the Monocryl suture group. Randomization is performed using a computer model. To minimize confounders, the pre-operative preparation and antibiotics regime will be standardized. The closure of the fascia and the skin will also be performed by at least a Registrar. The wounds will then be covered with a thick sterile dressing to blind the patient and the research assistant. The wound will only be reviewed on the POD 3. The patient is scheduled to return on POD 14, POD 30, 3 and 6 months post operatively upon discharge. Some of the variables that will be collected for this study include: 1. Time taken for skin closure 2. Superficial surgical site infection 3. Pain score 4. Cosmesis We aim to enrol 72 participants in each group. Importance/Impact to Medicine This study will validate the role of Monocryl suture as an effective method for skin closure following open colectomy. We believe Monocryl sutured closure can potentially change the practice of surgeons worldwide for the benefits of the patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

4.1 years

First QC Date

June 14, 2013

Last Update Submit

July 22, 2013

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Superficial surgical site infection

    up till 6months post-op

Secondary Outcomes (3)

  • 1. Time taken for skin closure

    up till 6months post-op

  • 2. Pain score

    up till 6months post op

  • 3. Cosmesis

    up till 6months post op

Study Arms (2)

Monocryl suture skin closure

ACTIVE COMPARATOR

Monocryl skin suture

Procedure: monocryl skin suture

Stapled skin closure

ACTIVE COMPARATOR

stapled skin closure

Procedure: stapled skin closure

Interventions

stapled skin closurePROCEDURE

as above

Stapled skin closure
monocryl skin suturePROCEDURE

as above

Monocryl suture skin closure

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who underwent elective open colectomy for various etiologies

You may not qualify if:

  • Emergency laparotomies
  • Patient who require the creation of a stoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Frederick H Koh, MBBS

    NUHS Surgery

    STUDY CHAIR

  • Wai-Kit Cheong, FRCS

    NUHS Surgery

    PRINCIPAL INVESTIGATOR

  • Bettina Lieske, FRCS

    NUHS Surgery

    PRINCIPAL INVESTIGATOR

  • Ker-Kan Tan, FRCS

    NUHS Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick H Koh, MBBS

CONTACT

+65-84281117frederickkohhx@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Division, Division of Colorectal Surgery

Study Record Dates

First Submitted

June 14, 2013

First Posted

July 25, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

SG(1)