Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00933829
Other study ID # 12177
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2009
Est. completion date September 2010

Study information

Verified date June 2020
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this prospective, randomized study is to compare cosmetic outcomes between absorbable and non-absorbable sutures in truncal and extremity lacerations in the pediatric and adult population. Secondary outcome measures include wound complications such as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid formation after three months post repair.


Description:

Even though there some studies showing good outcomes using absorbable sutures in skin closure in clean surgical wounds, ED based studies still need to be conducted to convince ED physicians that the use of absorbable sutures to close the skin in traumatic lacerations are just as acceptable as traditional non-absorbable sutures. Use of absorbable sutures confers several advantages over non-absorbable sutures. For one, patients do not need an additional physician visit either in the office, or more often that not, in the emergency department. These visits add to ED overcrowding, prolonged length of ED stay and are often not reimbursed if seen in the emergency department. Moreover, adult patients need to miss work or school and children often have to miss school or daycare to have these sutures removed. The potential to avert another traumatic experience from suture removal in children who had been restrained for suture placement is another advantage of using absorbable sutures over non-absorbable sutures.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 65 Years
Eligibility Inclusion Criteria:

1. Isolated injury

2. Non-contaminated or minimally contaminated wounds

3. Linear laceration 1-5 cms

4. Topical adhesives not indicated

Exclusion Criteria:

1. Trunk and extremity lacerations less than 1 cm or greater than 5 cm.

2. Moderately contaminated wounds or dirty wounds

3. Wounds with visible foreign bodies

4. Wounds more than 8 hours old

5. Wounds that can be repaired using topical adhesives

6. Complex wounds needing surgical referral

7. Wounds caused by mammalian bites

8. Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction

9. Wounds in patients who are currently taking steroids

10. Wounds in areas of tension such as the joint or crease

11. Patients with allergic reaction to the topical anesthetic

12. Irregular wounds

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Absorbable Suture Arm
use of irradiated polyglactin 910
Device:
Non-absorbable suture (Prolene)
suture
Procedure:
suture
non-absorable sutures and absorable sutures

Locations

Country Name City State
United States Temple University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Al-Qattan MM. Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. J Hand Surg Br. 2005 Feb;30(1):90-1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale. at least 3 months post-injury
Secondary Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury. 8-12 days post-injury
See also
  Status Clinical Trial Phase
Completed NCT02865902 - Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness N/A
Terminated NCT01191567 - Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Recruiting NCT00737425 - Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery Phase 4
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Terminated NCT00762138 - The AutoloGelâ„¢ Post-Market Surveillance (TAPS) Program N/A
Withdrawn NCT00234559 - Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Completed NCT02591537 - OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University N/A
Completed NCT00792688 - Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation Phase 2
Recruiting NCT05608317 - A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing N/A
Recruiting NCT02195063 - Survey Study for Pain Management, Wound Care, Scar Care or UDT Phase 4
Completed NCT01319149 - A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes N/A
Completed NCT00153452 - Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners N/A
Completed NCT06083740 - A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Not yet recruiting NCT02672280 - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects Phase 1/Phase 2
Withdrawn NCT02314416 - Stem Cells In Wound Healing With Collagen Matrix as a Carrier Phase 4
Recruiting NCT01454167 - Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications N/A