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Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

Primary Purpose

Surgical Incisions

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Suture
Dermabond Protape (Prineo)
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Incisions focused on measuring Abdominoplasty, Body Lift, Plastic Surgery, Skin Closure, Wound Healing, Dermabond

Eligibility Criteria

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

Inclusion Criteria:

  • Be at least 18 years of age;
  • Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
  • Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
  • Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study;
  • Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)], six (± 1 month) and twelve months (± 1 month)];
  • Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and
  • Sign the informed consent.

Exclusion Criteria:

  • Have peripheral vascular disease;
  • Have insulin dependent diabetes mellitus;
  • Be known to have a blood clotting disorder;
  • Be receiving antibiotic therapy for pre-existing condition or infection;
  • Be known to be HIV-positive or otherwise immunocompromised;
  • Have known personal or family history of keloid formation or hypertrophy;
  • Be currently taking systemic steroids;
  • Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
  • Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
  • Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.

Sites / Locations

  • UZ
  • Dreifaltigkeits-Krankenhaus
  • Markus Krankenhaus
  • Akademikliniken
  • Mid Essex Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

Dermabond Protape-Incision segments are randomized & patient is own control

Intradermal Suture - Incision segments are randomized & patient is own control. Investigator selected suture on the basis of standard local practice.

Outcomes

Primary Outcome Measures

Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.
Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.

Secondary Outcome Measures

Time Required to Close the Final Skin Layer
Time to close final skin layer for each incision segment.
Cosmetic Outcome
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Cosmetic Outcome
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Cosmetic Outcome
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.

Full Information

First Posted
November 9, 2007
Last Updated
June 13, 2012
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00557947
Brief Title
Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions
Official Title
Multi-centre Study to Show Equivalence of Prineo (Dermabond Protape) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incisions
Keywords
Abdominoplasty, Body Lift, Plastic Surgery, Skin Closure, Wound Healing, Dermabond

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Dermabond Protape-Incision segments are randomized & patient is own control
Arm Title
II
Arm Type
Active Comparator
Arm Description
Intradermal Suture - Incision segments are randomized & patient is own control. Investigator selected suture on the basis of standard local practice.
Intervention Type
Device
Intervention Name(s)
Suture
Other Intervention Name(s)
Investigator selected the intradermal suture per standard local practice.
Intervention Description
intradermal and topical suturing
Intervention Type
Device
Intervention Name(s)
Dermabond Protape (Prineo)
Other Intervention Name(s)
Prineo
Intervention Description
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
Primary Outcome Measure Information:
Title
Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.
Description
Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.
Time Frame
12-25 days post-operation
Secondary Outcome Measure Information:
Title
Time Required to Close the Final Skin Layer
Description
Time to close final skin layer for each incision segment.
Time Frame
Intraoperative
Title
Cosmetic Outcome
Description
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time Frame
90 days post-procedure
Title
Cosmetic Outcome
Description
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time Frame
6 months
Title
Cosmetic Outcome
Description
Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age; Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications; Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure; Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study; Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)], six (± 1 month) and twelve months (± 1 month)]; Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and Sign the informed consent. Exclusion Criteria: Have peripheral vascular disease; Have insulin dependent diabetes mellitus; Be known to have a blood clotting disorder; Be receiving antibiotic therapy for pre-existing condition or infection; Be known to be HIV-positive or otherwise immunocompromised; Have known personal or family history of keloid formation or hypertrophy; Be currently taking systemic steroids; Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Colquhoun, MD
Organizational Affiliation
Pleiad Devices
Official's Role
Study Director
Facility Information:
Facility Name
UZ
City
Gent
Country
Belgium
Facility Name
Dreifaltigkeits-Krankenhaus
City
Cologne
Country
Germany
Facility Name
Markus Krankenhaus
City
Frankfurt
Country
Germany
Facility Name
Akademikliniken
City
Stockholm
Country
Sweden
Facility Name
Mid Essex Hospital
City
Broomfield
State/Province
Essex
Country
United Kingdom

12. IPD Sharing Statement

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Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

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