Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000399998
Ethics application status
Approved
Date submitted
29/03/2011
Date registered
15/04/2011
Date last updated
23/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized study comparing skin closure in benign gynecologic surgery : Staple versus subcuticular suture
Scientific title
A randomized study comparing skin closure in benign gynecologic surgery:Staple versus subcuticular suture for postoperative pain
Secondary ID [1] 259840 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 265407 0
benign gynecologic surgery 265534 0
Condition category
Condition code
Anaesthesiology 265567 265567 0 0
Pain management
Surgery 265691 265691 0 0
Surgical techniques
Reproductive Health and Childbirth 265812 265812 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Staple: A wire like fastening device composed of steel – based alloys , used to close operative wound. It will be removed at one week after the procedure.
Intervention code [1] 264259 0
Treatment: Devices
Intervention code [2] 264347 0
Treatment: Surgery
Comparator / control treatment
Arm 2: Absorbable subcuticular suture: A method of skin closure involving placement of stitchs in the subcuticular tissue pararelled with the line of the wound. The suture material will be absorbed around 21 days after the procedure.
Control group
Active

Outcomes
Primary outcome [1] 262370 0
Postoperative pain by using visual analog scale (VAS)
Timepoint [1] 262370 0
At two months after randomization
Secondary outcome [1] 273646 0
Wound infection by medical record at 30 days after the procedure.
Timepoint [1] 273646 0
At one month after randomization
Secondary outcome [2] 273647 0
Satisfaction of patient by using Patient Satisfaction Questionnaire (PSQ)
Timepoint [2] 273647 0
At one month after randomization

Eligibility
Key inclusion criteria
-Scheduled to undergo benign gynecologic surgery
-Performing Pfannenstiel incision
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Previous pfannenstiel incision
-Malignant condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interventions are put sequentially in sealed opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated using block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 3215 0
Thailand
State/province [1] 3215 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 264715 0
Hospital
Name [1] 264715 0
Khon Kaen Hospital
Country [1] 264715 0
Thailand
Primary sponsor type
Hospital
Name
Khon Kaen Hospital
Address
56 Srichan Road
Muang
Khon Kaen
40000
Country
Thailand
Secondary sponsor category [1] 263880 0
Other
Name [1] 263880 0
Medical Education Center
Address [1] 263880 0
56 Srichan Road
Muang
Khon Kaen
40000
Country [1] 263880 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266739 0
Khon Kaen Hospital Ethics Committee
Ethics committee address [1] 266739 0
56 Srichan Road
Muang
Khon Kaen
40000
Ethics committee country [1] 266739 0
Thailand
Date submitted for ethics approval [1] 266739 0
02/08/2010
Approval date [1] 266739 0
09/09/2010
Ethics approval number [1] 266739 0
77/01/2553

Summary
Brief summary
A transverse suprapubic (Pfannenstiel) incision is widely used in gynecologic surgery and cesarean delivery, and associated with a better cosmetic result. The goal of any skin closure technique is to produce appropriate skin approximation and adequate healing with minimal wound complications, scarring, pain, and cost. The technique should be quick, cost-effective, and simple, while maximizing wound cosmesis and patient satisfaction. Two methods for skin closure are used: metallic staples or subcuticular sutures. The method chosen relies mostly on the surgeon’s preference. The impact of the method used on postoperative pain, aesthetic results, and incidence of infections remains controversial. Most trials have suggested that staples are superior in speed of closure but have provided conflicting results regarding rates of infection, evaluation of cosmesis, postoperative pain, and cost-effectiveness. There were insufficient data to compare the effectiveness of these two methods, most of gynecologists individually choose their preferred methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32243 0
Address 32243 0
Country 32243 0
Phone 32243 0
Fax 32243 0
Email 32243 0
Contact person for public queries
Name 15490 0
Manasicha Mekjarasnapha
Address 15490 0
Department of Obstetrics and Gynacology
Khon Kaen Hospital
56 Srichan Road
Muang
Khon Kaen
40000
Country 15490 0
Thailand
Phone 15490 0
66815749876
Fax 15490 0
6643-336789 Ext 3736
Email 15490 0
[email protected]
Contact person for scientific queries
Name 6418 0
Sitthipong Thawinkarn
Address 6418 0
Department of Obstetrics and Gynecology
Khon Kaen Hospital
56 Srichan Road
Muang
Khon Kaen
40000
Country 6418 0
Thailand
Phone 6418 0
66877755907
Fax 6418 0
6643336789 Ext 3736
Email 6418 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.