NCT00571363

Brief Summary

We have compared to types of surgery to assess which one leaves the smaller surgical defect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
Last Updated

December 12, 2007

Status Verified

December 1, 2007

First QC Date

December 11, 2007

Last Update Submit

December 11, 2007

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

  • defect size after surgery

    immediately after surgery

Study Arms (2)

standard surgery

ACTIVE COMPARATOR

basal cell carcinomas were excised with 4 mm margins

Procedure: standard surgery

Mohs

ACTIVE COMPARATOR

Basal cell carcinoma were removed via Mohs Micrographic surgery

Procedure: Mohs micrographic surgery

Interventions

standard surgeryPROCEDURE

excision with 4 mm margins

standard surgery
Mohs micrographic surgeryPROCEDURE

excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.

Mohs

Eligibility Criteria

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

You may qualify if:

  • Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears

You may not qualify if:

  • Subjects of less than 18 years of age
  • Subjects unable to comply with instructions,
  • Immunosuppressed subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital and Medical School

Dundee, DD3 6TU, United Kingdom

Location

Related Publications (1)

  • Muller FM, Dawe RS, Moseley H, Fleming CJ. Randomized comparison of Mohs micrographic surgery and surgical excision for small nodular basal cell carcinoma: tissue-sparing outcome. Dermatol Surg. 2009 Sep;35(9):1349-54. doi: 10.1111/j.1524-4725.2009.01240.x. Epub 2009 Jun 3.

    PMID: 19500127DERIVED

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Mohs Surgery

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

MicrosurgerySurgical Procedures, OperativeDermatologic Surgical ProceduresPlastic Surgery Procedures

Study Officials

  • Frank M Muller

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2006

Last Updated

December 12, 2007

Record last verified: 2007-12

Locations

GB(1)