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Trial record 4 of 7 for:    "Gigantomastia"

Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

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ClinicalTrials.gov Identifier: NCT00558246
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : July 19, 2012
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Macromastia
Interventions Device: Dermabond Protape (Prineo)
Device: Suture
Enrollment 79
Recruitment Details Subjects were recruited from the genreal popluation of those undergoing elective, bilateral breast surgery.
Pre-assignment Details  
Arm/Group Title Prineo and Suture
Hide Arm/Group Description On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Period Title: Overall Study
Started 79
Completed 79
Not Completed 0
Arm/Group Title Prineo and Suture
Hide Arm/Group Description On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
<=18 years
0
   0.0%
Between 18 and 65 years
78
  98.7%
>=65 years
1
   1.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
79
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants
Belgium 10
Germany 47
United Kingdom 6
Sweden 16
1.Primary Outcome
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.
Hide Description Equivalence was 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) did not exceed 12 percent.
Time Frame 12-25 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis is based upon intent to treat population.
Arm/Group Title Prineo Suture
Hide Arm/Group Description:
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Overall Number of Participants Analyzed 79 79
Measure Type: Number
Unit of Measure: Participants
76 76
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prineo, Suture
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in proportion of successes
Estimated Value 0
Confidence Interval (2-Sided) 95%
-5.9 to 5.9
Estimation Comments The level of significance for statistical testing was 0.05 for this study.
2.Secondary Outcome
Title Time (Minutes) Required to Close the Final Skin Layer
Hide Description Overall time required to close final skin layer on each breast.
Time Frame Intraoperative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis is based upon the Intent to Treat population.
Arm/Group Title Prineo Suture
Hide Arm/Group Description:
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Overall Number of Participants Analyzed 79 79
Mean (Standard Deviation)
Unit of Measure: minutes
2.56  (1.34) 16.22  (6.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prineo, Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Cosmetic Outcome
Hide 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 breasts with good outcomes were then compared to those with poor outcomes in each group.

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.
Arm/Group Title Prineo Suture
Hide Arm/Group Description:
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Incisions with good outcome
49 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prineo, Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
4.Secondary Outcome
Title Cosmetic Outcome
Hide 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 breasts with good outcomes were then compared to those with poor outcomes in each group.

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 60 participants who completed all follow-up visits and cosmetic evaluations.
Arm/Group Title Prineo Suture
Hide Arm/Group Description:
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Incisions with good outcome
37 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prineo, Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2266
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
5.Secondary Outcome
Title Cosmetic Outcome
Hide 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 breasts with good outcomes were then compared to those with poor outcomes in each group.

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 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 59 participants who completed all follow-up visits and cosmetic evaluations.
Arm/Group Title Prineo Suture
Hide Arm/Group Description:
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: Incisions with good outcome
40 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prineo, Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5078
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Time Frame 90+/-10 days following treatment
Adverse Event Reporting Description Recorded as reported whether spontaneously volunteered or in response to questioning about well-being at all follow-up visits.
 
Arm/Group Title Prineo Suture Procedure
Hide Arm/Group Description On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
All-Cause Mortality
Prineo Suture Procedure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prineo Suture Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/79 (0.00%)      0/79 (0.00%)      2/79 (2.53%)    
Infections and infestations       
Sepsis  1 [1]  0/79 (0.00%)  0 0/79 (0.00%)  0 1/79 (1.27%)  1
Skin and subcutaneous tissue disorders       
Elective Brachioplasty  1 [2]  0/79 (0.00%)  0 0/79 (0.00%)  0 1/79 (1.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Following treatment, patient experienced postoperative sepsis and was hospitalized. Patient required surgical reintervention and was treated with antibiotics. No action was taken with respect to the study.
[2]
Subject underwent planned bilateral brachioplasty for hanging skin. The event required hospitalisation for medical/surgical intervention. In the opinion of the Investigator, the event was classified as not related to sutures or Prineo.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prineo Suture Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/79 (39.24%)      21/79 (26.58%)      50/79 (63.29%)    
Gastrointestinal disorders       
Nausea  1 [1]  3/79 (3.80%)  3 2/78 (2.56%)  2 12/79 (15.19%)  12
General disorders       
Pain  1  17/79 (21.52%)  17 15/79 (18.99%)  15 18/79 (22.78%)  18
Injury, poisoning and procedural complications       
Procedure Pain  1  6/79 (7.59%)  6 6/79 (7.59%)  6 16/79 (20.25%)  16
Open Wound  1  4/79 (5.06%)  4 2/79 (2.53%)  2 6/79 (7.59%)  6
Psychiatric disorders       
Insomnia  1 [2]  1/79 (1.27%)  1 1/79 (1.27%)  1 4/79 (5.06%)  4
Skin and subcutaneous tissue disorders       
Blistering  1  8/79 (10.13%)  8 0/0  0 5/79 (6.33%)  5
Pruritus  1 [3]  3/79 (3.80%)  3 2/78 (2.56%)  2 5/79 (6.33%)  5
Vascular disorders       
Hematoma  1 [4]  3/79 (3.80%)  3 1/79 (1.27%)  1 9/79 (11.39%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Nausea was assessed as not related to device but to procedure.
[2]
Events assessed not related device but to procedure.
[3]
Itchiness at application site assessed as not related to device but to procedure.
[4]
Events assessed as not related to device but to procedure.
Limitations of this study include the fact that the patient served as her own control. Additionally, as in many device studies, because of the obvious difference in the investigated and the control devices, blinding was limited.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Phyllis Britnell
Organization: Ethicon
Phone: 1 908 218-3060
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00558246     History of Changes
Other Study ID Numbers: 07CS003
First Submitted: November 9, 2007
First Posted: November 14, 2007
Results First Submitted: June 13, 2012
Results First Posted: July 19, 2012
Last Update Posted: July 19, 2012