Laparotomy Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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