Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638736
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2020-07-01
Brief Title:
A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative withdrawal study was never approved by IRB
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to compare outcomes in patient comfort cosmetic appearance and complication rates between sutures and staples in high tension areas for closures of skin cancers excised in a dermatology clinic
Detailed Description:
I Purpose Background and Rationale A Aim and Hypotheses
1 Standard of care for epidermal wound closure in dermatology is generally considered to be sutures however many specialties utilize staples due to their increased speed of closure In particular high tension wound areas within dermatology may be more suitable for closure with staples given their higher tensile strength when compared to sutures
2 The hypothesis is that for high tension areas
1 Staples will provide improved cosmetic outcomes compared with sutures along with a reduction in closure times
2 Patient comfort during the placement of staples as well as the healing and removal process will be no different than what patients with sutures experience
B Background and Significance
1 Study Significance
The intent of this research project is to help determine if sutures or staples are superior in high tension areas on the trunk and extremities in regards to cosmetic outcome and patient comfort or if there are no differences between the two This will help physicians when deciding between these two closure techniques The idea for this project came as the investigators saw the majority of our attendings preferring sutures but some preferring staples citing greater tensile strength One of the rationale the investigators have heard for preferring sutures is improved patient comfort however anecdotally some patients that have had both sutures and staples have reported not different in comfort with closure and removal between the two
2 Literature review Similar studies have been done comparing sutures vs staples especially for obstetrics and orthopedics One study comparing subcutaneous sutres vs staples for emergency C-sections showed improved cosmetic outcomes shorter duration of surgery and comparable post op pain and complications1
C Rationale Anecdotal reports from patients report minimal to no difference with closure and removal of sutures vs staples and there is no current literature comparing the two This study will help establish if there is a difference between these two closure techniques in patient comfort and will also compare cosmetic outcomes
II Research Plan and Design
A Study Objectives
This randomized controlled trial will look at how different closure techniques impact closure appearance and patient comfort for placement and removal for two commonly used closure materials ie suture or staples in areas that are under high tension Both of these closure techniques are already commonly used in clinical practice but there are no studies comparing them to each other This information can help guide dermatologic surgeons to pick the best method of closing a wound that is under tension
B Study Type and Design
Randomized prospective clinical trial with 2 groups 1 group with high tension area wounds closed with sutures n50 and 1 group with high tension area wounds closed with staples n50 Follow up periods will be 2 weeks for suturestaple removal and at 6 months for final cosmetic outcome
C Sample size statistical methods and power calculation 1 Randomization will be done with a random number generator the day of the surgery Randomization ratio will be 11 T test chi squared and linear regression will be used to analyze the data
2 One blinded physician will be used Sutures or staples will be removed by a nurse and the patient will be asked not to inform the physician of the closure method at time of assessment Code for the blinding will be held by the principle investigator Circumstancesprocedure for breaking the code will be in the event of a significant complication and can be done by looking back in the patients chart or asking the patient which method was used
3 Number of subjects to be enrolled has been determined based on other similar studies assessing scar appearance and by online calculators developed to determine number of subjects needed for a power of 80-90 This sample size should allow us to detect if there are statistically significant differences in patient comfort and scar appearance
Subject Criteria See Vulnerable Populations appendix if applicable
1 Inclusion criteria 18 and over Any race or gender Willing to return to KU for follow up clinic visits on at least 2 occasions 2 week for suture or staple removal and 6 month for scar assessment can be done at 6 month follow up for full body skin exam- both would be standard of care
Lesion location on high tension area as defined by back shoulder scapula elbow scalp Incisions between the lengths of 3cm to 12 cm Skin pathology as defined by BCC SCC Melanoma
2 Exclusion criteria
History of keloid or excessive scar formation potential impact on cosmetic outcome Contraindication to lidocaine with epinephrine potential impact to comfort during procedure Contraindication or skin sensitivity to suture or staple material potential impact to comfort and cosmetic outcome
1 WithdrawalTermination criteria NA
2 Participants may participate in another research study while participating in this one
E Specific methods and techniques used throughout the study
1 Laboratory tests None
2 Study Procedures Procedure done in the study include excision of skin cancer according to standards of care with a standard excision kit followed by a standard of care repair of the wound using either sutures vs staples See attached for 3 patient surveys time 5 minutes per survey and for physician scar assessment 5 minutes for assessment
3 SurveysQuestionnaires and assessment of scar are performed for research purposes the rest is standard of care
4 NA
5 Timeline Day 1- informed consent patient randomized into a closure group excision and repair of skin cancer performed patient fills out a questionnaire Day 2- two weeks after excision questionnaire on healing period suture or staple removal scar assessment patient questionnaire about comfort with removal of sutures or staples Day 3- 6 month follow up assessment of scar before or after patients appointment for a full body skin exam See attached
F Riskbenefit assessment
1 Physical risk Potential risk for discomfort or worsened cosmetic outcome in one arm of the study both methods are considered within standard of care currently
2 Psychological risk None
3 Social risk Appearance of scar both methods are considered within standard of care currently
4 Economic risk None
5 Potential benefit of participating in the study
1 Individual - this study could help establish a superior method of closure that could be used if they need an excision in a high tension area in the future
2 Population - none
3 To science- this study could help determine if one of these methods of closure is superior to the other in terms of cosmetic outcome and patient discomfort G Location where study will be performed University of Kansas Medical Office Building
1 Standard of care for epidermal wound closure in dermatology is generally considered to be sutures however many specialties utilize staples due to their increased speed of closure In particular high tension wound areas within dermatology may be more suitable for closure with staples given their higher tensile strength when compared to sutures
2 The hypothesis is that for high tension areas
1 Staples will provide improved cosmetic outcomes compared with sutures along with a reduction in closure times
2 Patient comfort during the placement of staples as well as the healing and removal process will be no different than what patients with sutures experience
B Background and Significance
1 Study Significance
The intent of this research project is to help determine if sutures or staples are superior in high tension areas on the trunk and extremities in regards to cosmetic outcome and patient comfort or if there are no differences between the two This will help physicians when deciding between these two closure techniques The idea for this project came as the investigators saw the majority of our attendings preferring sutures but some preferring staples citing greater tensile strength One of the rationale the investigators have heard for preferring sutures is improved patient comfort however anecdotally some patients that have had both sutures and staples have reported not different in comfort with closure and removal between the two
2 Literature review Similar studies have been done comparing sutures vs staples especially for obstetrics and orthopedics One study comparing subcutaneous sutres vs staples for emergency C-sections showed improved cosmetic outcomes shorter duration of surgery and comparable post op pain and complications1
C Rationale Anecdotal reports from patients report minimal to no difference with closure and removal of sutures vs staples and there is no current literature comparing the two This study will help establish if there is a difference between these two closure techniques in patient comfort and will also compare cosmetic outcomes
II Research Plan and Design
A Study Objectives
This randomized controlled trial will look at how different closure techniques impact closure appearance and patient comfort for placement and removal for two commonly used closure materials ie suture or staples in areas that are under high tension Both of these closure techniques are already commonly used in clinical practice but there are no studies comparing them to each other This information can help guide dermatologic surgeons to pick the best method of closing a wound that is under tension
B Study Type and Design
Randomized prospective clinical trial with 2 groups 1 group with high tension area wounds closed with sutures n50 and 1 group with high tension area wounds closed with staples n50 Follow up periods will be 2 weeks for suturestaple removal and at 6 months for final cosmetic outcome
C Sample size statistical methods and power calculation 1 Randomization will be done with a random number generator the day of the surgery Randomization ratio will be 11 T test chi squared and linear regression will be used to analyze the data
2 One blinded physician will be used Sutures or staples will be removed by a nurse and the patient will be asked not to inform the physician of the closure method at time of assessment Code for the blinding will be held by the principle investigator Circumstancesprocedure for breaking the code will be in the event of a significant complication and can be done by looking back in the patients chart or asking the patient which method was used
3 Number of subjects to be enrolled has been determined based on other similar studies assessing scar appearance and by online calculators developed to determine number of subjects needed for a power of 80-90 This sample size should allow us to detect if there are statistically significant differences in patient comfort and scar appearance
Subject Criteria See Vulnerable Populations appendix if applicable
1 Inclusion criteria 18 and over Any race or gender Willing to return to KU for follow up clinic visits on at least 2 occasions 2 week for suture or staple removal and 6 month for scar assessment can be done at 6 month follow up for full body skin exam- both would be standard of care
Lesion location on high tension area as defined by back shoulder scapula elbow scalp Incisions between the lengths of 3cm to 12 cm Skin pathology as defined by BCC SCC Melanoma
2 Exclusion criteria
History of keloid or excessive scar formation potential impact on cosmetic outcome Contraindication to lidocaine with epinephrine potential impact to comfort during procedure Contraindication or skin sensitivity to suture or staple material potential impact to comfort and cosmetic outcome
1 WithdrawalTermination criteria NA
2 Participants may participate in another research study while participating in this one
E Specific methods and techniques used throughout the study
1 Laboratory tests None
2 Study Procedures Procedure done in the study include excision of skin cancer according to standards of care with a standard excision kit followed by a standard of care repair of the wound using either sutures vs staples See attached for 3 patient surveys time 5 minutes per survey and for physician scar assessment 5 minutes for assessment
3 SurveysQuestionnaires and assessment of scar are performed for research purposes the rest is standard of care
4 NA
5 Timeline Day 1- informed consent patient randomized into a closure group excision and repair of skin cancer performed patient fills out a questionnaire Day 2- two weeks after excision questionnaire on healing period suture or staple removal scar assessment patient questionnaire about comfort with removal of sutures or staples Day 3- 6 month follow up assessment of scar before or after patients appointment for a full body skin exam See attached
F Riskbenefit assessment
1 Physical risk Potential risk for discomfort or worsened cosmetic outcome in one arm of the study both methods are considered within standard of care currently
2 Psychological risk None
3 Social risk Appearance of scar both methods are considered within standard of care currently
4 Economic risk None
5 Potential benefit of participating in the study
1 Individual - this study could help establish a superior method of closure that could be used if they need an excision in a high tension area in the future
2 Population - none
3 To science- this study could help determine if one of these methods of closure is superior to the other in terms of cosmetic outcome and patient discomfort G Location where study will be performed University of Kansas Medical Office Building
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None