A Prospective Comparison of Suture Removal Time for Simple Surgical Defects of the Head and Neck

NCT02166996 | Completed

• 1 other identifier: Dnr 2011-56-31M
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, prospective, randomized comparison with blinded assessment of cosmetic outcome. To compare cosmetic outcome of surgical defects of head and neck, repaired with non-resorbable monofilament sutures from the aspect of suture removal time 7 and 14 days. Data are gathered through a standardized form at the time of surgery concerning width and length of the surgical excisions, and if the patient has any systemic cortisone treatment or diabetes mellitus. At the time of surgery the patients are randomised to a suture time at 7 or 14 days postoperatively and all receive the same written information about postoperative care and restrictions. Photographs of the scars are taken one month and one year after the procedure and rated using a visual analogue scale (VAS) by three independent assessors blinded to the intervention and suture time. The width of the scar is measured after one ear. Study hypothesis is that leaving non-resorbable monofilament sutures in clean surgical wounds in the head and neck area for up to 14 days does not lead to poor cosmetic outcome.

Conditions

Cutaneous Tumors

Outcome Measures

Primary Outcomes (1)

• Cosmetic assessment of scar

  assessment of scar with Visual Analog Cosmesis Scale after one month and one year. 3 blinded assessors.

  One month and one year

Secondary Outcomes (1)

• width of scar

  one year

Other Outcomes (1)

• Suture/puncture marks

  One year

Study Arms (2)

A

ACTIVE COMPARATOR

Suture removal time 7 days.

Procedure: Suture removal time 7 days

B

EXPERIMENTAL

Suture removal time 14 days.

Procedure: Suture removal time14 days

Interventions

Suture removal time 7 days PROCEDURE

To compare cosmetic outcome of surgical defects of head and neck, repaired with non-resorbable monofilament nylon sutures from the aspect of suture removal time 7 days.

A

Suture removal time14 days PROCEDURE

To compare cosmetic outcome of surgical defects of head and neck, repaired with non-resorbable monofilament nylon sutures from the aspect of suture removal time 14 days

B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing simple surgical excisions of suspected cutaneous malignancies in the head and neck and at least 18 years of age.

You may not qualify if:

• The use of local flaps or grafts.
• Not being able to understand the study protocol and the instructions given.
• Reoperation of the included wound/scar before study completion

Sponsors & Collaborators

• Sundsvall Hospital: lead

Study Sites (1)

Sundsvall-Härnösand County Hospital

Sundsvall, Medelpad, 85186, Sweden

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sarah Maleki, MD

  Sundsvall Hospital

  PRINCIPAL INVESTIGATOR

• Eva Westman, MD, PhD

  Sundsvall Hospital, Umeå University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2013
• First Posted: June 18, 2014
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 18, 2014

Record last verified: 2012-12

Locations

SE (1)