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PDS vs Polyamide for Midline Abdominal Closure (PPMAC)
This study has been terminated.
( Unacceptable incidence of wound dehiscence in the PDS group )
Study NCT00514566   Information provided by Christian Medical College and Hospital, Ludhiana, India
First Received: August 8, 2007   No Changes Posted

August 8, 2007
August 8, 2007
October 2004
 
Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain [ Time Frame: 2 years ]
Same as current
No Changes Posted
Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma [ Time Frame: 2 years ]
Same as current
 
PDS vs Polyamide for Midline Abdominal Closure
Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial

Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.

 
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Laparotomy
Device: Suture for midline abdominal closure
Active Comparator: Surgical Patient undergoing midline laparotomy closure
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
64
April 2006
 

Inclusion Criteria:

  • All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria:

  • All patients under 12 years of age
  • Gynaecological operations
  • Abdominal wall hernia repair
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00514566
 
ChristianMCLudhiana
Christian Medical College and Hospital, Ludhiana, India
 
Study Chair: Rajeev Kapoor, MS(Gen Surg) Christian Medical College and Hospital, Ludhiana, India
Christian Medical College and Hospital, Ludhiana, India
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP