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

Primary Purpose

Surgical Wound

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical staples
Subcuticular sutures
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring Head and neck surgery, Scar cosmesis, Surgical staples, Sutures, Patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Surgical staples

Sutures

Arm Description

Skin closure with surgical staples

Skin closure with subcuticular sutures

Outcomes

Primary Outcome Measures

Patient and Observer Scar Assessment Survey (POSAS)
Survey score - to assess for scar cosmesis outcome

Secondary Outcome Measures

Patient Satisfaction Survey
Survey score - to assess for patient satisfaction
Wound complications - dehiscence
Wound dehiscence
Wound complications - infection
Surgical site infections

Full Information

First Posted
June 29, 2016
Last Updated
October 5, 2017
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02936063
Brief Title
Outcomes Comparing Different Methods of Skin Closure in Patients Undergoing Head and Neck Surgery.
Official Title
Outcomes Comparing Different Methods of Skin Closure in Patients Undergoing Head and Neck Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI left the institution before any participants were enrolled.
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The goal of the study is to evaluate and compare patient perception of two different methods of skin closure following head and neck surgery. Currently, the standard of care includes closing with surgical staples or subcuticular sutures, and is decided at surgeon's discretion. Both methods are used in accordance with the standard of care at Boston Medical Center, depending on individual physician preference. There are also factors that may influence choice of closure at time of surgery, such as operative time, or wound characteristics. For instance, if the operative time was already extending longer than expected, to decrease patient anesthesia time, the surgeon may opt for staples, since they are faster to place than sutures. Also, although a rare scenario, if there was excessive blood loss during the surgery or the surgeon has reason to suspect post-operative hematoma development, they will likely opt for staple closure, to facilitate easy post-operative access to the wound if necessary. In the literature, incidence of hematoma as a post-operative complication to head and neck surgery is stated as 3-4.7%. There have been various studies in the literature comparing these two skin closure methods for general surgery (abdominal procedures) and obstetrics/gynecological surgeries, with inconclusive outcomes. We found a lack of data in the literature describing head and neck surgeries. Given the different type of wounds, and the often more visible nature of the resulting scars, the investigators believe there is value to accessing patient perception of skin closure in this cohort. Kobayashi et al. conducted a large randomized control trial of 1264 subjects, comparing staples vs. subcuticular sutures after open and laparoscopic elective colorectal cancer surgery. The results of the study showed no significant difference in operative outcomes (wound complications, surgical site infections, post-operative length of stay, scar esthetics). However, staples were found to have a shorter operative time, while sutures resulted in statistically significant higher patient satisfaction. A meta-analysis of 12 studies comparing sutures and staples in caesarian section showed no difference in patient satisfaction or scar cosmesis, but found more wound complications in the staples arm. Much of the existing data are reported from general surgery or obstetrics/gynecology. There is not a lot of literature in otolaryngology or head and neck surgery that evaluates skin closure methods. The importance of cosmetic outcomes and patient satisfaction is particularly important in the field of head and neck surgery, due to the visibility of the scars given their location. Upon review of the existing literature, there is no definitive data to support either method as superior, with regards to wound complications and outcomes, mature scar cosmesis, or post-operative pain. There is some evidence to suggest that subcuticular suture closure is marginally superior with regards to scar cosmesis, but given that operative time is increased, there is not enough benefit to the patient to change the standard of care. In addition, with the current trend of medicine moving towards patient-reported outcomes, it becomes increasingly important to evaluate patient satisfaction to determine whether there is a superior method. The investigators hypothesize that there will be no statistically significant difference between staple skin closure and subcuticular suture closure, with regards to the primary outcomes of patient satisfaction and mature scar cosmesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
Head and neck surgery, Scar cosmesis, Surgical staples, Sutures, Patient satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical staples
Arm Type
Experimental
Arm Description
Skin closure with surgical staples
Arm Title
Sutures
Arm Type
Experimental
Arm Description
Skin closure with subcuticular sutures
Intervention Type
Procedure
Intervention Name(s)
Surgical staples
Intervention Description
Closure of surgical wound at skin level with surgical staples
Intervention Type
Procedure
Intervention Name(s)
Subcuticular sutures
Intervention Description
Closure of surgical wound at skin level with subcuticular sutures
Primary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Survey (POSAS)
Description
Survey score - to assess for scar cosmesis outcome
Time Frame
2 years post-operative
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey
Description
Survey score - to assess for patient satisfaction
Time Frame
2 years post-operative
Title
Wound complications - dehiscence
Description
Wound dehiscence
Time Frame
2 years post-operative
Title
Wound complications - infection
Description
Surgical site infections
Time Frame
2 years post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scharukh Jalisi, MD, MA
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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