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Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Primary Purpose

Wound Infection, Wound Complication

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
4-0 monofilament suture
Stainless steel staples
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection focused on measuring Wound infection, Wound separation, Skin staples, Subcuticular suture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy.
  • Body mass index >=30
  • Benign or oncologic indications for surgery.
  • Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
  • Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Pfannenstiel or transverse abdominal incision
  • Concomitant panniculectomy or plastic surgery
  • Women <18 years of age
  • History of prior abdominal or pelvic radiation
  • Inability to sign an informed consent form prior to registration on study
  • Inability to understand spoken or written English
  • Prisoner
  • Mental incapacity
  • A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stainless Steel Staples

4-0 monofilament Sutures

Arm Description

Skin closure with stainless steel staples

Skin closure with 4-0 monofilament sutures

Outcomes

Primary Outcome Measures

Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.

Secondary Outcome Measures

Incidence of Wound Disruption
Incidence of Wound Infection
Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.
Operative Time
Time from skin incision to the end of skin closure
Analog Pain Score on Postoperative Days 3-4
The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.
Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score
Ranges from 0 (worst) to 5 (best) Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0
Median Patient Satisfaction Score of Scar Appearance
Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.

Full Information

First Posted
April 17, 2013
Last Updated
July 26, 2017
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01977612
Brief Title
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Official Title
Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2013 (Actual)
Primary Completion Date
June 17, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.
Detailed Description
The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection, Wound Complication
Keywords
Wound infection, Wound separation, Skin staples, Subcuticular suture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stainless Steel Staples
Arm Type
Active Comparator
Arm Description
Skin closure with stainless steel staples
Arm Title
4-0 monofilament Sutures
Arm Type
Experimental
Arm Description
Skin closure with 4-0 monofilament sutures
Intervention Type
Device
Intervention Name(s)
4-0 monofilament suture
Other Intervention Name(s)
4-0 Monocryl suture
Intervention Description
Skin closure using 4-0 monofilament suture
Intervention Type
Device
Intervention Name(s)
Stainless steel staples
Intervention Description
Skin closure using stainless steel staples.
Primary Outcome Measure Information:
Title
Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
Time Frame
4-8 weeks post-surgery
Secondary Outcome Measure Information:
Title
Incidence of Wound Disruption
Time Frame
4-8 weeks post-surgery
Title
Incidence of Wound Infection
Description
Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.
Time Frame
4-8 weeks post-surgery
Title
Operative Time
Description
Time from skin incision to the end of skin closure
Time Frame
During surgery
Title
Analog Pain Score on Postoperative Days 3-4
Description
The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.
Time Frame
3-4 days post-surgery
Title
Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score
Description
Ranges from 0 (worst) to 5 (best) Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0
Time Frame
4-8 weeks post-operative
Title
Median Patient Satisfaction Score of Scar Appearance
Description
Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.
Time Frame
4-8 weeks post-operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy. Body mass index >=30 Benign or oncologic indications for surgery. Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery. Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Women who are pregnant or breastfeeding Pfannenstiel or transverse abdominal incision Concomitant panniculectomy or plastic surgery Women <18 years of age History of prior abdominal or pelvic radiation Inability to sign an informed consent form prior to registration on study Inability to understand spoken or written English Prisoner Mental incapacity A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Kuroki, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Randomized Clinical Trial of Skin Closure With Staples Versus Suture

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