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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. |
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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 † | 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:
Exclusion Criteria:
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| 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 † |
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| 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 | ||||