Outcomes Comparing Different Methods of Skin Closure in Patients Undergoing Head and Neck Surgery.

NCT02936063 | Withdrawn DMC

• 1 other identifier: H-34701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

When patients undergo neck dissection surgeries, the current standard of care is to close the skin layer with either metal staples, which are removed a few days post-operatively, or with sutures, which can be absorbable or removed. To date, there is no conclusive data in the literature that definitively suggests one method is better than the other, with regard to wound complications or mature scar cosmesis. Currently, skin closure method is chosen by each individual surgeon, and is based on personal preference, factoring in evaluation of the wound. The goal of the study is to compare the two methods of skin closure, and the measured outcomes the investigators will be looking at are patient satisfaction, wound complications, and mature scar cosmesis. The investigators will be randomizing patients undergoing head and neck surgery to receive either staples or subcuticular sutures, and giving them surveys at their post-operative clinic visits to evaluate the outcomes, to determine if patients perceive one method to be superior to the other.

Conditions

Surgical Wound

Keywords

Head and neck surgery; Scar cosmesis; Surgical staples; Sutures; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient and Observer Scar Assessment Survey (POSAS)

  Survey score - to assess for scar cosmesis outcome

  2 years post-operative

Secondary Outcomes (3)

• Patient Satisfaction Survey

  2 years post-operative

• Wound complications - dehiscence

  2 years post-operative

• Wound complications - infection

  2 years post-operative

Study Arms (2)

Surgical staples

EXPERIMENTAL

Skin closure with surgical staples

Procedure: Surgical staples

Sutures

EXPERIMENTAL

Skin closure with subcuticular sutures

Procedure: Subcuticular sutures

Interventions

Surgical staples PROCEDURE

Closure of surgical wound at skin level with surgical staples

Surgical staples

Subcuticular sutures PROCEDURE

Closure of surgical wound at skin level with subcuticular sutures

Sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Ability to speak/read English language
• Adult patients (age \> 18)
• Willing to have follow-up appointments (per clinical care protocol)
• Both genders

You may not qualify if:

• Prior radiation therapy to the head and neck region (prior to surgery)
• Prior surgery to the head and neck region (at the judgement of investigator)
• Pregnancy

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Surgical Wound; Patient Satisfaction

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Scharukh Jalisi, MD, MA

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: October 18, 2016
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)