NCT01773447

Brief Summary

The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2.6 years

First QC Date

January 15, 2013

Last Update Submit

March 29, 2017

Conditions

Basal Cell CarcinomaSquamous Cell CarcinomaMelanoma

Outcome Measures

Primary Outcomes (2)

  • Mean of sum of 2 blinded reviewers Physician Observer Assessment scores

    Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows: a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.

    3 months

  • Scar width

    Width of scar in millimeters for each side of scar measured 1 cm from the midline.

    3 months

Secondary Outcomes (1)

  • Height of scar immediately following wound closure

    5 minutes

Study Arms (2)

Set-back suture

ACTIVE COMPARATOR

Wound to be close by set-back suture technique.

Procedure: Set-back suture

Vertical mattress suture technique

ACTIVE COMPARATOR

Wound to be closed by vertical mattress technique.

Procedure: Vertical mattress suture

Interventions

Set-back suturePROCEDURE
Set-back suture
Vertical mattress suturePROCEDURE
Vertical mattress suture technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elliptical surgical wound that needs to be closed with a layered closure
  • Wound 3 cm in length or longer

You may not qualify if:

  • Incarceration
  • Active pregnancy
  • Less than 18 years of age
  • Unable to give informed consent
  • Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
  • Wound closure projected to be less than 3 cm in length
  • Skin less than 3 mm in thickness (dermis and epidermis combined)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous CellMelanoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous CellNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Daniel Eisen, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

August 1, 2011

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

US(1)