- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07319572
Comparison of Chest Tube Wound Closure: Comparison Between Purse String Method and Plug Method.
Optimizing Chest Tube Removal: A Comparison of Purse-string Suture Closure and Plug Method.
Study Overview
Status
Intervention / Treatment
Detailed Description
Chest tube removal often results in small but cosmetically significant wounds. The traditional purse-string suture technique is widely used due to its presumed ability to ensure air-tight closure; however, it is frequently associated with circular or puckered scars that affect cosmetic appearance. Recently, the simple suture/plug method has been proposed as a more cosmetic alternative while maintaining adequate wound integrity.
This study prospectively enrolls patients requiring chest tube removal and allocates them to one of the two wound closure techniques. Standardized postoperative care is provided to all participants. The primary outcome is cosmetic appearance of the scar, evaluated using a validated scar assessment scale at follow-up. Secondary outcomes include wound infection, seroma or discharge, persistent air leak, wound dehiscence, time to healing, and patient satisfaction.
The findings are expected to help clinicians select the most effective and cosmetically favorable method for chest tube wound closure in routine surgical practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Fahad Ali Ali, MBBS
- Phone Number: +923320601136
- Email: joyafahad@gmail.com
Study Locations
-
-
Islamabad
-
Islamabad, Islamabad, Pakistan
- Pakistan Institute of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria :
- All patients >18 years of age
- Patients undergoing chest tube insertion for traumatic causes including Pneumothorax, hemothorax and hemopneumothorax.
Exclusion criteria:
- Previous ipsilateral thoracic surgery
- Patients with large wounds necessitating suture closure
- Patients with bleeding disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Purse string group
Patients in this arm will have the chest tube removal site closed using a purse-string suture technique.
After chest tube removal and haemostasis, a single circumferential (purse-string) stitch is placed around the wound margin and tightened to approximate the skin edges.
Skin is left approximated; additional superficial interrupted skin sutures may be applied at the investigator's discretion.
Suture material: monofilament nylon or silk, per local practice.
Standard sterile dressing applied.
Post-procedure wound care and follow-up are identical to the comparator arm.
|
PURSE STRING METHOD OF CLOSURE: A circumferential suture is placed around the chest tube insertion site before or after tube removal. The suture is tightened like a drawstring to approximate the skin edges and close the wound. This method provides an air-tight seal but often results in a puckered, circular scar. PLUG METHOD OF CLOSURE: After chest tube removal, the tract is allowed to collapse naturally and is gently plugged with a small gauze piece impregnated with petroleum jelly. |
|
Experimental: Plug Method group
After chest tube removal, the wound is swiftly plugged off with an impregnable gauze and no sutures applied.
The gauze is then fixed with air tight dressing
|
An impregnable gauze which is made airtight by coating it in petroleum jelly is swiftly placed over the chest wound site as the chest tube is removed and an air tight dressing done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Incidence of air leak after chest tube removal using purse-string suture or plug method"
Time Frame: 48 hours
|
It is the incidence of air leak/pneumothorax after the chest tube has been removed and the wound is closed by one of the two methods of chest tube wound closure; 1) the purse string method of chest tube wound closure and 2) the plug method of chest tube wound closure.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of wound infection after chest tube site closure using purse-string suture or plug method
Time Frame: 7 Days
|
Development of surgical site infection at the chest tube removal site after closure by purse-string suture or plug method, defined according to standard surgical site infection criteria
|
7 Days
|
|
Scar appearance score at chest tube site measured using the Vancouver Scar Scale
Time Frame: 1 month
|
Scar quality at the chest tube removal site assessed using the Vancouver Scar Scale, which evaluates pigmentation, vascularity, pliability, and height
|
1 month
|
|
Patient-reported cosmetic satisfaction score after chest tube site closure measured using a Numerical Rating Scale
Time Frame: 1 month
|
Patient-reported cosmetic satisfaction with the chest tube removal site assessed using a Numerical Rating Scale, where: 0 = not satisfied at all 10 = completely satisfied Higher scores indicate better cosmetic satisfaction. |
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-5-2/2024(ERCC)/PIMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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