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PDS vs Polyamide for Midline Abdominal Closure (PPMAC)

This study has been terminated.
Study NCT00514566.   Last updated on August 8, 2007.   Information provided by Christian Medical College and Hospital, Ludhiana, India

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Descriptive Information Fields
Brief Title  PDS vs Polyamide for Midline Abdominal Closure
Official Title  Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial
Brief Summary

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.

Detailed Description

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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain [ Time Frame: 2 years ]
Secondary Outcome Measure  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 ]
Condition  Laparotomy
Intervention  Device: Suture for midline abdominal closure
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  64
Start Date  October 2004
Completion Date April 2006
Eligibility Criteria 

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
Gender Both
Ages 12 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  India
Administrative Information Fields
NCT ID  NCT00514566
Organization ID ChristianMCLudhiana
Secondary IDs ††
Study Sponsor  Christian Medical College and Hospital, Ludhiana, India
Collaborators ††
Investigators 
Study Chair:     Rajeev Kapoor, MS(Gen Surg)     Christian Medical College and Hospital, Ludhiana, India    
Information Provided By Christian Medical College and Hospital, Ludhiana, India
Verification Date August 2007
First Received Date  August 8, 2007
Last Updated Date August 8, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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