PDS vs Polyamide for Midline Abdominal Closure (PPMAC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Laparotomy |
Device: Suture for midline abdominal closure |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 64 |
| Study Start Date: | October 2004 |
| Study Completion Date: | April 2006 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| India | |
| Christian Medical College and Hospital | |
| Ludhiana, Punjab, India, 141008 | |
| Study Chair: | Rajeev Kapoor, MS(Gen Surg) | Christian Medical College and Hospital, Ludhiana, India |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00514566 History of Changes |
| Other Study ID Numbers: | ChristianMCLudhiana |
| Study First Received: | August 8, 2007 |
| Last Updated: | August 8, 2007 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Christian Medical College and Hospital, Ludhiana, India:
|
Polyamide Polydioxanone Midline Abdominal Closure |
ClinicalTrials.gov processed this record on May 16, 2013