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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 8, 2007 | ||||
| Last Updated Date | August 8, 2007 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain [ Time Frame: 2 years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | PDS vs Polyamide for Midline Abdominal Closure | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Laparotomy | ||||
| Intervention ICMJE | Device: Suture for midline abdominal closure | ||||
| Study Arms / Comparison Groups | Active Comparator: Surgical Patient undergoing midline laparotomy closure | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 64 | ||||
| Completion Date | April 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00514566 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | ChristianMCLudhiana | ||||
| Study Sponsor ICMJE | Christian Medical College and Hospital, Ludhiana, India | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Christian Medical College and Hospital, Ludhiana, India | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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