PDS vs Polyamide for Midline Abdominal Closure (PPMAC)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial|
- Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain [ Time Frame: 2 years ]
- 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 ]
|Study Start Date:||October 2004|
|Study Completion Date:||April 2006|
Active Comparator: 1
Surgical Patient undergoing midline laparotomy closure
Device: Suture for midline abdominal closure
closure with Polyamide or Polydioxanone
Other Name: Ethicon Inc., Loop no. 1, 150 cm suture length
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514566
|Christian Medical College and Hospital|
|Ludhiana, Punjab, India, 141008|
|Study Chair:||Rajeev Kapoor, MS(Gen Surg)||Christian Medical College and Hospital, Ludhiana, India|